A Study of JNJ-77474462 (Bermekimab) in Healthy Chinese Participants

NCT05252520 | Withdrawn Phase 1 FDA Drug

• 2 other identifiers: CR10910977474462HDS1001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-77474462 following single ascending dose subcutaneous (SC) administration to healthy Chinese participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• Maximum Observed Serum Concentration (Cmax) of JNJ-77474462

  Cmax is defined as the maximum observed serum concentration of JNJ-77474462.

  Up to Day 85

• Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-77474462

  Tmax is defined as the time to reach maximum observed serum concentration of JNJ-77474462.

  Up to Day 85

• Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinity]) of JNJ-77474462

  AUC (0-infinity) is defined as the area under the serum concentration of JNJ-77474462 versus time curve from time zero to infinity with extrapolation of the terminal phase.

  Up to Day 85

• Area Under the Serum 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 the area under the serum concentration of JNJ-77474462 versus time curve from time zero to the time corresponding to the last quantifiable concentration.

  Up to Day 85

• Terminal Half-life (T1/2) of JNJ-77474462

  T1/2 will be reported. T1/2 is defined as the terminal half-life of JNJ-77474462.

  Up to Day 85

• Apparent Total Systemic Clearance after Extravascular Administration (CL/F) of JNJ-77474462

  CL/F is defined as the apparent total systemic clearance after extravascular administration of JNJ-77474462.

  Up to Day 85

• Apparent Volume of Distribution Based on Terminal Phase After Extravascular Administration (Vz/F) of JNJ-77474462

  Vz/F is defined as the apparent volume of distribution based on terminal phase after extravascular administration of JNJ-77474462.

  Up to Day 85

Secondary Outcomes (8)

• Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity

  Up to Day 85

• Percentage of Participants with Serious Adverse Events (SAEs)

  Up to Day 85

• Number of Participants with Clinically Significant Changes in Vital Signs

  Up to Day 85

• Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs)

  Up to Day 85

• Number of Participants with Clinically Significant Changes in Hematology Parameters

  Up to Day 85

Study Arms (1)

JNJ-77474462

EXPERIMENTAL

Participants will receive a single subcutaneous (SC) Dose 1 of JNJ-77474462 on Day 1 in Cohort 1, a single SC Dose 2 of JNJ-77474462 on Day 1 in Cohort 2 and a single SC Dose 3 of JNJ-77474462 on Day 1 in Cohort 3.

Drug: JNJ-77474462

Interventions

JNJ-77474462 DRUG

JNJ-77474462 will be administered subcutaneously.

Also known as: Bermekimab

JNJ-77474462

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have a body mass index (BMI) between 18 and 27.9 kilograms per meter square (kg/m\^2) (BMI = weight/height\^2), inclusive, and a body weight of between 50 to 90 kg, inclusive
• Otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day -2 to -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
• A female of childbearing potential must have a negative pregnancy test at screening and on Day -2 to -1
• Must have 3 quadrants on the abdomen where the skin is not tender, bruised, red, scaly, hardened, or tattooed for subcutaneous (SC) administration
• Must be a nonsmoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study

You may not qualify if:

• 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
• History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 12 months before Screening or positive test result(s) for alcohol or drugs of abuse (including morphine, ketamine, tetrahydrocannabinolic acid, methamphetamine, dimethylene dioxoamphetamine, cocaine) at Screening and Day -2 to -1
• Have a history of active granulomatous infection (including histoplasmosis or coccidioidomycosis), nontuberculous mycobacterial infection or opportunistic infection (including pneumocystosis, aspergillosis, and disseminated herpes zoster defined as zoster with central nervous system involvement or zoster spreading to more than 2 adjacent dermatomes)
• Has a chest radiograph within 3 months before the first administration of study intervention that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis (TB). A chest computerized tomography (CT) scan is also acceptable if already available or obtained outside of the study protocol
• Has tested positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and treponema pallidum-specific antibody

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

MeSH Terms

Interventions

bermekimab

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 23, 2022
• Study Start: May 1, 2023
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share