A Study of JNJ-77474462 (Bermekimab) in Healthy Participants of Japanese Descent Following Administration of Single Ascending Subcutaneous Doses

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

The purpose of the study is to assess the safety and tolerability of JNJ-77474462 following single subcutaneous (SC) administration to healthy participants of Japanese descent.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: JNJ-77474462; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Herston, Australia, 4006
    • Nucleus Network, Q-Pharm Pty Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: JNJ-77474462; JNJ-77474462 will be administered as SC injection.; Other Names: Bermekimab; Drug: Placebo; Matching placebo to JNJ-77474462 will be administered as 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.	Drug: JNJ-77474462; JNJ-77474462 will be administered as SC injection.; Other Names: Bermekimab; Drug: Placebo; Matching placebo to JNJ-77474462 will be administered 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.	Drug: JNJ-77474462; JNJ-77474462 will be administered as SC injection.; Other Names: Bermekimab; Drug: Placebo; Matching placebo to JNJ-77474462 will be administered as SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)	An adverse event (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 AEs with onset or worsening on or after date of first dose of study treatment.	Up to Week 16
Number of Participants with Serious Adverse Events (SAEs)	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.	Up to Week 16
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC) Reported in two or More Participants	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 AEs with onset or worsening on or after date of first dose of study treatment.	Up to Week 16
Number of Participants with Clinically Significant Changes in Vital Signs	Number of participants with clinically significant changes in vital signs (temperature, pulse/heart rate, respiratory rate, blood pressure) will be reported.	Up to Week 12
Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs) Waveform	Number of participants with clinically significant changes in ECGs waveform (example: changes in T-wave morphology or the occurrence of U-waves) will be reported.	Up to Week 12
Number of Participants with Clinically Significant Changes in Hematology	Number of participants with clinically significant changes in hematology (such as platelet count, Red blood cell count [RBS], Hemoglobin, Hematocrit, RBC Indices, WBCs) will be reported.	Up to Week 12
Number of Participants with Clinically Significant Changes in Chemistry	Number of participants with clinically significant changes in chemistry (such as Sodium, Potassium, Chloride, Bicarbonate,glucose, Total bilirubin, Uric acid) will be reported.	Up to Week 12
Number of Participants with Clinically Significant Changes in Urinalysis	Number of participants with clinically significant changes in urinalysis (such as Specific gravity, pH, Glucose,Protein, WBCs, Bacteria) will be reported.	Up to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Concentration (Cmax)	Cmax is the maximum observed concentration.	Up to Week 12
Area Under the Plasma/Serum Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity])	AUC(0-infinity) is defined area under the plasma/serum concentration versus time curve from time zero to infinity with extrapolation of the terminal phase.	Up to Week 12
Area Under the Plasma/Serum Concentration-time Curve from Time Zero To Time Of the Last Quantifiable Concentrations (AUC[0-last])	AUC(0-last) is defined as area under the plasma/serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration.	Up to Week 12
Time to Reach Maximum Observed Concentration (Tmax)	Tmax is the time to reach maximum observed concentration.	Up to Week 12
Terminal Half-life (T1/2)	T1/2 is the terminal half-life.	Up to Week 12
Apparent Total Systemic Clearance (CL/F)	CL/F is the apparent total systemic clearance after extravascular administration.	Up to Week 12
Apparent Volume of Distribution (Vz/F)	Vz/F is the apparent volume of distribution based on terminal phase after extravascular administration.	Up to Week 12
Number of Participants with Antibodies to JNJ-77474462	Number of participants with antibodies to JNJ-77474462 in participants receiving active study active intervention in total and by intervention group will be reported.	Up to Week 12

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Actual): August 5, 2021
• Study Completion (Actual): August 5, 2021

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CR108807; 77474462ADM1002 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No