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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

Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants
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
Secondary ID [1] 0 0
212979
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK3858279
Treatment: Drugs - Placebo

Experimental: Participants receiving GSK3858279 -

Placebo comparator: Participants receiving placebo -


Treatment: Drugs: GSK3858279
GSK3858279 will be administered

Treatment: Drugs: Placebo
Placebo will be administered
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events (AEs), serious AE(SAE) and withdrawals due to AEs
Timepoint [1] 0 0
Up to 173 days
Primary outcome [2] 0 0
Change from Baseline in hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and platelet count (Giga cells per liter)
Timepoint [2] 0 0
Baseline and up to 173 days
Primary outcome [3] 0 0
Change from Baseline in hematology Parameter: Red blood cell count (RBC) (Trillion cells per liter)
Timepoint [3] 0 0
Baseline and up to 173 days
Primary outcome [4] 0 0
Change from Baseline in hematology Parameter: Hemoglobin (Grams per Liter)
Timepoint [4] 0 0
Baseline and up to 173 days
Primary outcome [5] 0 0
Change from Baseline in hematology Parameter: Hematocrit (Proportion of red blood cells in blood
Timepoint [5] 0 0
Baseline and up to 173 days
Primary outcome [6] 0 0
Change from Baseline in hematology Parameter: RBC indices (Millions per cubic millimeter)
Timepoint [6] 0 0
Baseline and up to 173 days
Primary outcome [7] 0 0
Change from Baseline in hematology Parameter: Mean Corpuscular Volume (MCV) (Femtoliters)
Timepoint [7] 0 0
Baseline and up to 173 days
Primary outcome [8] 0 0
Change from Baseline in hematology Parameter: Mean corpuscular hemoglobin (MCH) (picograms)
Timepoint [8] 0 0
Baseline and up to 173 days
Primary outcome [9] 0 0
Change from Baseline in hematology Parameter: Reticulocytes (Percentage of reticulocytes)
Timepoint [9] 0 0
Baseline and up to 173 days
Primary outcome [10] 0 0
Change from Baseline in clinical chemistry parameters: Alanine Amino Transferase (ALT),Alkaline Phosphatase (ALP),Aspartate Amino Transferase (AST) (International units per Liter)
Timepoint [10] 0 0
Baseline and up to 173 days
Primary outcome [11] 0 0
Change from Baseline in clinical chemistry parameters: Calcium, glucose (non-fasting), potassium, sodium,urea (Millimoles per Liter)
Timepoint [11] 0 0
Baseline and up to 173 days
Primary outcome [12] 0 0
Change from Baseline in clinical chemistry parameters: Creatinine, direct bilirubin, total bilirubin (Micromoles per liter)
Timepoint [12] 0 0
Baseline and up to 173 days
Primary outcome [13] 0 0
Change from Baseline in clinical chemistry parameters: Total protein (Grams per liter)
Timepoint [13] 0 0
Baseline and up to 173 days
Primary outcome [14] 0 0
Change from Baseline in Urinalysis parameter: Urine Specific Gravity (Ratio of urine density to water density)
Timepoint [14] 0 0
Baseline and up to 173 days
Primary outcome [15] 0 0
Change from Baseline in Urinalysis parameter: Urine Potential of Hydrogen (pH)
Timepoint [15] 0 0
Baseline and up to 173 days
Primary outcome [16] 0 0
Number of Participants With Abnormal Urinalysis Results by Dipstick Method
Timepoint [16] 0 0
Up to 173 days
Primary outcome [17] 0 0
Change from Baseline in vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) (Millimeters of mercury)
Timepoint [17] 0 0
Baseline and up to 173 days
Primary outcome [18] 0 0
Change from Baseline in vital sign : Pulse rate (Beats per minute)
Timepoint [18] 0 0
Baseline and up to 173 days
Primary outcome [19] 0 0
Change from Baseline in vital signs: Body temperature ( Degrees Celsius)
Timepoint [19] 0 0
Baseline and up to 173 days
Primary outcome [20] 0 0
Change from Baseline in vital signs: Respiratory rate (Breaths per minute)
Timepoint [20] 0 0
Baseline and up to 173 days
Primary outcome [21] 0 0
Change from Baseline in vital signs:Heart Rate (Beats per minute)
Timepoint [21] 0 0
Baseline and up to 173 days
Primary outcome [22] 0 0
Change from Baseline in Electrocardiogram (ECG) parameters: PR Interval, QRS Duration, QT Interval and QT interval corrected for heart rate according Fridericia's formula (QTcF) Interval (Milliseconds)
Timepoint [22] 0 0
Baseline and up to 173 days
Primary outcome [23] 0 0
Area Under the plasma Concentration-Time Curve from Time zero to 56 Days [AUC(0-56)] of GSK3858279
Timepoint [23] 0 0
Upto 56 days
Primary outcome [24] 0 0
AUC from Time zero to the last measurable concentration (0-t) post-dose of GSK3858279
Timepoint [24] 0 0
Up to 173 days
Primary outcome [25] 0 0
Time of occurrence of last quantifiable concentration (tlast) of GSK3858279
Timepoint [25] 0 0
Up to 173 days
Primary outcome [26] 0 0
Maximum observed concentration (Cmax) of GSK3858279
Timepoint [26] 0 0
Up to 173 days
Primary outcome [27] 0 0
Time of occurrence of Cmax (tmax) of GSK3858279
Timepoint [27] 0 0
Up to 173 days
Secondary outcome [1] 0 0
Percent change from Baseline in free CCL17
Timepoint [1] 0 0
Baseline and at Days 7, 14, 28 and 56
Secondary outcome [2] 0 0
Cmax of total CCL17 in serum following GSK3858279
Timepoint [2] 0 0
Baseline and at Days 7, 14, 28 and 56
Secondary outcome [3] 0 0
tmax of total CCL17 in serum following GSK3858279
Timepoint [3] 0 0
Baseline and at Days 7, 14, 28 and 56
Secondary outcome [4] 0 0
Number of participants with indicated fold increase in total CCL17 in serum following GSK3858279
Timepoint [4] 0 0
Baseline and at Days 7, 14, 28 and 56
Secondary outcome [5] 0 0
Number of participants with pre-existing anti-drug antibodies (ADAs)
Timepoint [5] 0 0
Up to 173 days
Secondary outcome [6] 0 0
Number of participants with treatment-emergent ADAs over time
Timepoint [6] 0 0
Up to 173 days

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.
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/06/2023
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Herston
Recruitment hospital [2] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
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.
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05174013