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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04544813
Ethics application status
Date submitted
9/09/2020
Date registered
10/09/2020

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
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
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
Timepoint [3] 0 0
Up to Week 12
Primary outcome [4] 0 0
Terminal Half-Life (T1/2) of JNJ-77474462
Timepoint [4] 0 0
Up to Week 12
Primary outcome [5] 0 0
Absolute Subcutaneous (SC) Bioavailability (F%)
Timepoint [5] 0 0
Up to Week 12
Secondary outcome [1] 0 0
Percentage of Participants with Treatment-emergent Adverse Events (TEAE)
Timepoint [1] 0 0
Up to Week 12
Secondary outcome [2] 0 0
Percentage of Participants with Serious Adverse Events (SAE)
Timepoint [2] 0 0
Up to Week 12
Secondary outcome [3] 0 0
Number of Participants with Clinically Significant Changes in Vital Signs
Timepoint [3] 0 0
Up to Week 12
Secondary outcome [4] 0 0
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG)
Timepoint [4] 0 0
Up to Week 12
Secondary outcome [5] 0 0
Number of Participants with Clinically Significant Changes in Laboratory Findings
Timepoint [5] 0 0
Up to Week 12
Secondary outcome [6] 0 0
Number of Participants with Anti-JNJ-77474462 Antibodies
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/05/2021
Sample size
Target
Accrual to date
Final
78
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
Trial website
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
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?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


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/NCT04544813