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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04544826




Registration number
NCT04544826
Ethics application status
Date submitted
9/09/2020
Date registered
10/09/2020

Titles & IDs
Public title
A Study of JNJ-77474462 (Bermekimab) in Healthy Participants of Japanese Descent Following Administration of Single Ascending Subcutaneous Doses
Scientific title
A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of JNJ-77474462 (Bermekimab) in Healthy Participants of Japanese Descent Following Administration of Single Ascending Subcutaneous Doses
Secondary ID [1] 0 0
77474462ADM1002
Secondary ID [2] 0 0
CR108807
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 - Placebo

Experimental: Cohort 1: JNJ-77474462 (Low Dose) or Placebo - Participants will receive single low dose of JNJ-77474462 or matching placebo as subcutaneous (SC) injection.

Experimental: Cohort 2: JNJ-77474462 (Medium Dose) or Placebo - Participants will receive single medium dose of JNJ-77474462 or matching placebo as SC injection.

Experimental: Cohort 3: JNJ-77474462 (High Dose) or Placebo - Participants will receive single high dose of JNJ-77474462 or matching placebo as SC injection.


Treatment: Drugs: JNJ-77474462
JNJ-77474462 will be administered as SC injection.

Treatment: Drugs: Placebo
Matching placebo to JNJ-77474462 will be administered as SC injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to Week 16
Primary outcome [2] 0 0
Number of Participants with Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to Week 16
Primary outcome [3] 0 0
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC) Reported in two or More Participants
Timepoint [3] 0 0
Up to Week 16
Primary outcome [4] 0 0
Number of Participants with Clinically Significant Changes in Vital Signs
Timepoint [4] 0 0
Up to Week 12
Primary outcome [5] 0 0
Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs) Waveform
Timepoint [5] 0 0
Up to Week 12
Primary outcome [6] 0 0
Number of Participants with Clinically Significant Changes in Hematology
Timepoint [6] 0 0
Up to Week 12
Primary outcome [7] 0 0
Number of Participants with Clinically Significant Changes in Chemistry
Timepoint [7] 0 0
Up to Week 12
Primary outcome [8] 0 0
Number of Participants with Clinically Significant Changes in Urinalysis
Timepoint [8] 0 0
Up to Week 12
Secondary outcome [1] 0 0
Maximum Observed Concentration (Cmax)
Timepoint [1] 0 0
Up to Week 12
Secondary outcome [2] 0 0
Area Under the Plasma/Serum Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity])
Timepoint [2] 0 0
Up to Week 12
Secondary outcome [3] 0 0
Area Under the Plasma/Serum Concentration-time Curve from Time Zero To Time Of the Last Quantifiable Concentrations (AUC[0-last])
Timepoint [3] 0 0
Up to Week 12
Secondary outcome [4] 0 0
Time to Reach Maximum Observed Concentration (Tmax)
Timepoint [4] 0 0
Up to Week 12
Secondary outcome [5] 0 0
Terminal Half-life (T1/2)
Timepoint [5] 0 0
Up to Week 12
Secondary outcome [6] 0 0
Apparent Total Systemic Clearance (CL/F)
Timepoint [6] 0 0
Up to Week 12
Secondary outcome [7] 0 0
Apparent Volume of Distribution (Vz/F)
Timepoint [7] 0 0
Up to Week 12
Secondary outcome [8] 0 0
Number of Participants with Antibodies to JNJ-77474462
Timepoint [8] 0 0
Up to Week 12

Eligibility
Key inclusion criteria
* Participant must be of first to third generation Japanese descent
* Participant must be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day-1. 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
* Participant must be otherwise healthy on the basis of clinical laboratory tests performed at screening and Day-1. If the results of the serum chemistry panel including 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
* Participant must have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) (BMI = weight/height^2) and a body weight of between 50 to 90 kg inclusive
* A female participant must have a negative pregnancy test at screening and on Day -1
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Coexisting Medical Conditions or Past Medical History: 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, endocrine, neoplastic disease, renal or urinary tract diseases, or dermatological disease
* Coexisting Medical Conditions or Past Medical History: Has known allergies, hypersensitivity, or intolerance to JNJ-77474462 or its excipients, or any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or to any components of the formulation of JNJ-77474462 and its excipients used in this study
* Malignancy or Increased Potential for Malignancy: 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 and no evidence of recurrence within 5 years prior to screening
* Concomitant or Previous Medical Therapies Received: Participant 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)
* Concomitant or Previous Medical Therapies Received: Has received over the counter medications (including vitamins/multivitamins supplements, corticosteroids, acetaminophen/paracetamol, aspirin, decongestants, antihistamines and other non-steroidal anti-inflammatory drugs), and herbal medication (including, but not limited to, herbal tea, St. John's Wort, and cannabidol) within 2 weeks prior to first study intervention administration unless approved by the investigator and sponsor medical monitor
* Infections or Predisposition to Infections: has an active acute or clinically significant chronic infection

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
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
16/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/08/2021
Sample size
Target
Accrual to date
Final
24
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/NCT04544826