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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04544813




Registration number
NCT04544813
Ethics application status
Date submitted
9/09/2020
Date registered
10/09/2020
Date last updated
25/11/2020

Titles & IDs
Public title
A Study of JNJ-77474462 in Healthy Participants
Scientific title
A Phase 1 Study to Investigate the Pharmacokinetics and Pharmacodynamics of JNJ-77474462 in Healthy Participants
Secondary ID [1] 0 0
77474462ADM1001
Secondary ID [2] 0 0
CR108771
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-77474462
Treatment: Drugs - Anakinra

Experimental: Cohort A: JNJ-77474462 SC (Wave 1) - Participants will receive single dose of JNJ-77474462 subcutaneously (SC).

Experimental: Cohort B: JNJ-77474462 SC (Wave 1) - Participants will receive single dose of JNJ-77474462 SC.

Experimental: Cohort C: JNJ-77474462 SC (Wave 1) - Participants will receive single dose of JNJ-77474462 SC.

Experimental: Cohort D: JNJ-77474462 SC (Wave 1) - Participants will receive single dose of JNJ-77474462 SC.

Experimental: Cohort E: JNJ-77474462 IV (Wave 1) - Participants will receive single dose of JNJ-77474462 intravenously (IV).

Experimental: Cohort F: JNJ-77474462 SC (Wave 2) - Participants will receive single dose of JNJ-77474462 SC.

Experimental: Cohort G: JNJ-77474462 SC (Wave 2) - Participants will receive single dose of JNJ-77474462 SC.

Experimental: Cohort H: JNJ-77474462 IV (Wave 2) - Participants will receive single dose of JNJ-77474462 IV.

Experimental: Cohort I: JNJ-77474462 IV (Wave 2) - Participants will receive single dose of JNJ-77474462 IV.

Active Comparator: Cohort J: Anakinra SC - Participants will receive a SC injection of anakinra once daily for 3 days.


Treatment: Drugs: JNJ-77474462
Participants will receive JNJ-77474462 as a liquid formulation in Cohort A, B, C, D, F and G (SC injection) and in Cohort E, H and I (IV infusion).

Treatment: Drugs: Anakinra
Participants will receive a SC injection of anakinra 100 mg once daily for 3 days.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Observed Plasma Concentration (Cmax) of JNJ-77474462 - Cmax is the maximum observed plasma concentration.
Timepoint [1] 0 0
Up to Week 12
Primary outcome [2] 0 0
Area Under the Plasma Concentration Versus Time Curve from Time Zero to Infinity with Extrapolation of the Terminal Phase (AUC[0-infinity]) of JNJ-77474462 - AUC(0-infinity) is defined as area under the plasma concentration versus time curve from time zero to infinity with extrapolation of the terminal phase of JNJ-77474462.
Timepoint [2] 0 0
Up to Week 12
Primary outcome [3] 0 0
Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Time Corresponding to the Last Quantifiable Concentration (AUC[0-last]) of JNJ-77474462 - AUC(0-last) is defined as area under the plasma concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration of JNJ-77474462.
Timepoint [3] 0 0
Up to Week 12
Primary outcome [4] 0 0
Terminal Half-Life (T1/2) of JNJ-77474462 - T1/2 is defined as the time measured for the plasma concentration to decrease by 1 half of its original concentration.
Timepoint [4] 0 0
Up to Week 12
Primary outcome [5] 0 0
Absolute Subcutaneous (SC) Bioavailability (F%) - (F%) is defined as absolute SC bioavailability to be calculated using the following equation: AUC(0-infinity) SC/mean AUC(0-infinity) IV * 100 percent (%).
Timepoint [5] 0 0
Up to Week 12
Secondary outcome [1] 0 0
Percentage of Participants with Treatment-emergent Adverse Events (TEAE) - An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as adverse events (AEs) with onset or worsening on or after date of first dose of study treatment.
Timepoint [1] 0 0
Up to Week 12
Secondary outcome [2] 0 0
Percentage of Participants with Serious Adverse Events (SAE) - A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Timepoint [2] 0 0
Up to Week 12
Secondary outcome [3] 0 0
Number of Participants with Clinically Significant Changes in Vital Signs - Number of participants with clinically significant changes in vital signs (including body temperature, resting [supine] pulse/heart rate, respiratory rate and blood pressure) will be reported.
Timepoint [3] 0 0
Up to Week 12
Secondary outcome [4] 0 0
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) - Number of participants with clinically significant changes ECG will be reported.
Timepoint [4] 0 0
Up to Week 12
Secondary outcome [5] 0 0
Number of Participants with Clinically Significant Changes in Laboratory Findings - Number of participants with clinically significant changes in laboratory findings (that is, hematology, clinical chemistry, urinalysis) will be reported.
Timepoint [5] 0 0
Up to Week 12
Secondary outcome [6] 0 0
Number of Participants with Anti-JNJ-77474462 Antibodies - Number of participants with anti-drug antibodies to JNJ-77474462 will be reported.
Timepoint [6] 0 0
Up to Week 12

Eligibility
Key inclusion criteria
- Otherwise healthy on the basis of physical examination, medical history, vital signs,
and 12 lead electrocardiogram (ECG) performed at screening. Any abnormalities must be
considered not clinically significant and this determination must be recorded in the
participant's source documents and initialed by the investigator

- Otherwise healthy on the basis of clinical laboratory tests performed at screening and
Day 1. If the results of the serum chemistry panel, hematology, or urinalysis are
outside the normal reference ranges, the participant may be included only if the
investigator judges the abnormalities or deviations from normal to be not clinically
significant or to be appropriate and reasonable for the population under study. This
determination must be recorded in the participant's source documents and initialed by
the investigator

- A woman of childbearing potential must have a negative highly sensitive serum
beta-human chorionic gonadotropin (beta hCG) at screening and a negative urine
pregnancy test on Day -1

- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction during the study and for a period of 90 days post study intervention
administration

- A male participant must agree not to donate sperm for the purpose of reproduction
during the study and for a minimum of 90 days after receiving the last dose of study
intervention
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of any clinically significant medical illness or medical disorders the
investigator considers should exclude the participant, including (but not limited to),
neuromuscular, hematological disease, immune deficiency state, respiratory disease,
hepatic or gastrointestinal disease, neurological or psychiatric disease,
ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or
dermatological disease

- Has a history of malignancy before screening. Exceptions are squamous and basal cell
carcinomas of the skin, carcinoma in situ of the cervix, or a malignancy which is
considered cured with minimal risk of recurrence

- Has or has had a serious infection (example: sepsis, pneumonia, or pyelonephritis), or
have been hospitalized or received intravenous (IV) antibiotics for a serious
infection during the 4 months prior to the screening visit

- Is currently enrolled in an investigational study or has received an investigational
intervention (including investigational vaccines or devices) 5 half-lives or 8 weeks
prior to screening (whichever is longer)

- Has received prescription medications within 2 weeks prior to first study intervention
administration

Study design
Purpose of the study
Other
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network, Q-Pharm Pty Ltd - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-77474462 after single
subcutaneous (SC) or intravenous (IV) administrations and the effect of formulation
concentrations on PK of JNJ-77474462 in healthy participants.
Trial website
https://clinicaltrials.gov/show/NCT04544813
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
JNJ.CT@sylogent.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04544813