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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05174013
Registration number
NCT05174013
Ethics application status
Date submitted
22/12/2021
Date registered
30/12/2021
Date last updated
15/05/2025
Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants
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Scientific title
A Randomised, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Target Engagement and Immunogenicity of a Single Subcutaneous Dose of GSK3858279 Administered to Healthy Caucasian, Chinese and Japanese Participants
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Secondary ID [1]
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212979
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pain
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GSK3858279
Treatment: Drugs - Placebo
Experimental: GSK3858279 Caucasian - Participants received 240 milligrams (mg) of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
Experimental: GSK3858279 Chinese - Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
Experimental: GSK3858279 Japanese - Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
Placebo comparator: Caucasian Placebo - Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
Placebo comparator: Chinese Placebo - Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
Placebo comparator: Japanese Placebo - Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Treatment: Drugs: GSK3858279
GSK3858279 will be administered
Treatment: Drugs: Placebo
Placebo will be administered
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's
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Assessment method [1]
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An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169.
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Timepoint [1]
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Up to 169 days
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Primary outcome [2]
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Change From Baseline in Hematology Parameter of Platelet Count
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Assessment method [2]
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Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
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Timepoint [2]
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Baseline and Day 169
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Primary outcome [3]
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Change From Baseline in Hematology Parameter of Hemoglobin
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Assessment method [3]
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Blood samples were collected for the assessment of change from baseline in hematology parameters Hemoglobin. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
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Timepoint [3]
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Baseline and Day 169
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Primary outcome [4]
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Change From Baseline in Hematology Parameter of Hematocrit
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Assessment method [4]
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Blood samples were collected for the assessment of change from baseline in hematology parameters Hematocrit. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
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Timepoint [4]
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Baseline and Day 169
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Primary outcome [5]
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Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
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Assessment method [5]
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Blood samples were collected for the assessment of hematology parameters including (WBC) count with differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
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Timepoint [5]
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Baseline and Day 169
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Primary outcome [6]
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Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)
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Assessment method [6]
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Blood samples were collected for the assessment of clinical chemistry parameters including AST, ALT, AP. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
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Timepoint [6]
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Baseline and Day 169
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Primary outcome [7]
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Change From Baseline in Clinical Chemistry Parameter of Total Protein
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Assessment method [7]
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Blood samples were collected for the assessment of clinical chemistry parameters including total Protein. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
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Timepoint [7]
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Baseline and Day 169
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Primary outcome [8]
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Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin
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Assessment method [8]
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Blood samples were collected for the assessment of clinical chemistry parameters including Total bilirubin. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
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Timepoint [8]
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Baseline and Day 169
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Primary outcome [9]
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Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine
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Assessment method [9]
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Blood samples were collected for the assessment of clinical chemistry parameters including Direct bilirubin, Creatinine. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
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Timepoint [9]
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Baseline and Day 169
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Primary outcome [10]
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Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium
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Assessment method [10]
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Blood samples were collected for the assessment of clinical chemistry parameters including Urea, Glucose, Potassium, Sodium. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
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Timepoint [10]
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Baseline and Day 169
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Primary outcome [11]
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Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)
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Assessment method [11]
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Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
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Timepoint [11]
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Baseline and Day 169
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Primary outcome [12]
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Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)
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Assessment method [12]
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Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
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Timepoint [12]
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Baseline and Day 169
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Primary outcome [13]
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Number of Participants With Abnormal Urinalysis Results by Dipstick Method
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Assessment method [13]
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The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as increase to trace, increase to 1+ (low concentrations present), increase to 2+ (moderate concentrations present) and increase to 3+ (high concentrations present) indicating proportional concentrations in the urine sample. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for worst-case post-Baseline relative to Baseline is presented.
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Timepoint [13]
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Baseline and Day 169
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Primary outcome [14]
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Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
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Assessment method [14]
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The vital sign followed in this analysis was both systolic and diastolic blood pressure, expressed as millimetre of mercury. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
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Timepoint [14]
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Baseline and Day 169
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Primary outcome [15]
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Change From Baseline in Vital Signs: Pulse Rate
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Assessment method [15]
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The vital signs followed in this analysis was pulse rate, expressed as beats per minute. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
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Timepoint [15]
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Baseline and Day 169
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Primary outcome [16]
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Change From Baseline in Vital Signs: Body Temperature
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Assessment method [16]
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The vital sign followed in this analysis was body temperature, expressed as degree Celsius. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
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Timepoint [16]
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Baseline and Day 169
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Primary outcome [17]
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Change From Baseline in Vital Signs: Respiratory Rate
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Assessment method [17]
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The vital signs followed in this analysis was respiratory rate, expressed as Breaths per minute. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
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Timepoint [17]
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Baseline and Day 169
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Primary outcome [18]
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Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval
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Assessment method [18]
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Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
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Timepoint [18]
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Baseline and Day 169
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Primary outcome [19]
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Area Under the Plasma Concentration-Time Curve From Time Zero to 56 Days AUC (0-56)] of GSK3858279
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Assessment method [19]
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Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters. PK parameter population consist of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. This population was used in the assessment and characterization of PK parameters.
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Timepoint [19]
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Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43 and 57
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Primary outcome [20]
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AUC From Time Zero to the Last Measurable Concentration (0-t) Post-Dose of GSK3858279
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Assessment method [20]
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Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters. PK parameter population consist of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. This population was used in the assessment and characterization of PK parameters.
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Timepoint [20]
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Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
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Primary outcome [21]
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Time of Occurrence of Last Quantifiable Concentration (Tlast) of GSK3858279
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Assessment method [21]
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Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
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Timepoint [21]
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Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
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Primary outcome [22]
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Maximum Observed Concentration (Cmax) of GSK3858279
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Assessment method [22]
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Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
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Timepoint [22]
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Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
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Primary outcome [23]
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Time of Occurrence of Cmax (Tmax) of GSK3858279
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Assessment method [23]
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Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
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Timepoint [23]
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Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
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Secondary outcome [1]
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Percentage Change From Baseline in Free CCL17
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Assessment method [1]
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Blood samples were collected from participants at time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.
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Timepoint [1]
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Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
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Secondary outcome [2]
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Cmax of Total CCL17 in Serum Following GSK3858279
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Assessment method [2]
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Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
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Timepoint [2]
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Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
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Secondary outcome [3]
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Tmax of Total CCL17 in Serum Following GSK3858279
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Assessment method [3]
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Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.
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Timepoint [3]
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Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
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Secondary outcome [4]
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Maximum Fold Change in Total CCL17 in Serum Following GSK3858279 Administration
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Assessment method [4]
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Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
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Timepoint [4]
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Baseline (Day 1) and Days 56 Post dose
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Secondary outcome [5]
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Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration
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Assessment method [5]
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Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.
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Timepoint [5]
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Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
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Secondary outcome [6]
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Number of Participants With Pre-existing Anti-drug Antibodies (ADA's)
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Assessment method [6]
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Serum samples were collected for the determination of anti- GSK3858279 antibodies (ADA). The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.
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Timepoint [6]
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Day 169
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Secondary outcome [7]
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Number of Participants With Treatment-Emergent ADA's Over Time
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Assessment method [7]
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Serum samples were collected for the determination of anti- GSK3858279 antibodies (ADA).The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.
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Timepoint [7]
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Day 169
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Eligibility
Key inclusion criteria
* Participants between 20 and 65 years of age inclusive, at the time of signing the informed consent.
* Volunteers who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
* Participant capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Participants who have evidence of completed vaccination for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with an approved vaccine.
* Body weight within the range 45 - 100 killogram (kg) and body mass index (BMI) within the range 18-29.9 kg per meter square (/m2) (inclusive).
* Japanese participants are eligible based on meeting all of the following:
* Participants born in Japan
* Descendants of four ethnic Japanese grandparents and two ethnic Japanese parents.
* Have lived outside Japan for less than (<) 10 years at the time of screening
* Chinese participants are eligible based on meeting all of the following
* Participants born in mainland China, Hong Kong or Taiwan
* Descendants of four Chinese grandparents and two Chinese parents
* Have lived outside China, Hong Kong or Taiwan for <10 years at the time of screening
* Caucasian participants are eligible based on meeting the following
* Declaration of familial Caucasian/European ancestry (having 2 parents of Caucasian/European ancestry and 4 grandparents of Caucasian/European ancestry)
* Male or female participant
* Male participants are eligible to participate if they agree to the following for at least 28 weeks after the dose of study intervention: Refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR must agree to use contraception/barrier as detailed below: agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
* A female participant is eligible to participate if she is of non-reproductive potential.
* Capable of giving signed informed consent.
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Minimum age
20
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
* Personal or family history of cardiomyopathy.
* Abnormal blood pressure at screening as determined by the investigator.
* History of symptomatic herpes zoster.
* Evidence of active or latent tuberculosis (TB) as documented by medical history, examination, and TB testing with a positive (not indeterminate) QuantiFERON test.
* Significant allergies to humanized monoclonal antibodies as per principal investigator's and GSK medical monitor's judgements.
* History or evidence of clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
* History of lymphoma, leukaemia, or any malignancy within the last 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
ALT greater than (>)1.5 times upper limit of normal (ULN) .
* Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]).
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* Corrected QT (QTc) >450 milliseconds (msec).
* History of Stevens Johnson Syndrome.
* Known immunodeficiency.
* Participants with a chronic infection (for example [e.g.], osteomyelitis), who have been receiving treatment within three months prior to dosing or individuals with an active infection.
* Previous or current history of bleeding diathesis, excessive bleeding or coagulation disorders.
* History of significant medical illness in the opinion of the investigator would interfere with the study procedures and / or assessments.
* Intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing until final follow-up visit.
* Live vaccine(s) or plans to receive such vaccines within 1 month of screening until final follow-up visit.
* Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
* Treatment with antiplatelet or anticoagulant agents within 7 days of dosing.
* Major surgery (as per investigator's judgement) within 3 months prior to dosing.
* Participation in the study would result in loss of blood or blood products in excess of 500 milliliters (mL) within 3 months.
* Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
* Current enrolment or past participation in any other clinical study involving an investigational drug intervention within the last 3 months or 5 half-lives (whichever is longer) of signing the ICF.
* Presence of Hepatitis B surface antigen (HBsAg) at screening.
* Presence of the Hepatitis B core antibody (HBcAb) at screening.
* Positive Hepatitis C antibody test result at screening.
* Positive Hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention.
* Abnormal clinically significant echocardiogram at screening, as assessed by the investigator.
* Cardiac troponin or N-terminal pro B-type natriuretic peptide (NT-proBNP) levels out of normal range at screening.
* Positive pre-study drug/alcohol screen.
* Positive human immunodeficiency virus (HIV) antibody test.
* Positive coronavirus disease 2019 (COVID-19): SARS-CoV2 polymerase chain reaction (PCR) or lateral flow test of a combined throat and nasopharyngeal swab or nasal swab only.
* Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of >14 units for males and >14 units for females. One unit is equivalent to 8 grams of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
* Regular use of known drugs of abuse.
* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/04/2023
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Sample size
Target
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Accrual to date
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Final
33
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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GSK Investigational Site - Herston Queensland
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Recruitment hospital [2]
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GSK Investigational Site - Melbourne
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Recruitment postcode(s) [1]
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4006 - Herston Queensland
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), target engagement (TE) and immunogenicity of GSK3858279 when administered to healthy Caucasian, Chinese and Japanese participants.
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Trial website
https://clinicaltrials.gov/study/NCT05174013
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
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Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/13/NCT05174013/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/13/NCT05174013/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05174013
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