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

NCT ID: NCT04544826

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-16
• Study Completion Date: 2021-08-05

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1: JNJ-77474462 (Low Dose) or Placebo

Participants will receive single low dose of JNJ-77474462 or matching placebo as subcutaneous (SC) injection.

Group Type: EXPERIMENTAL

JNJ-77474462

Intervention Type: DRUG

JNJ-77474462 will be administered as SC injection.

Placebo

Intervention Type: DRUG

Matching placebo to JNJ-77474462 will be administered as SC injection.

Cohort 2: JNJ-77474462 (Medium Dose) or Placebo

Participants will receive single medium dose of JNJ-77474462 or matching placebo as SC injection.

Group Type: EXPERIMENTAL

JNJ-77474462

Intervention Type: DRUG

JNJ-77474462 will be administered as SC injection.

Placebo

Intervention Type: DRUG

Matching placebo to JNJ-77474462 will be administered as SC injection.

Cohort 3: JNJ-77474462 (High Dose) or Placebo

Participants will receive single high dose of JNJ-77474462 or matching placebo as SC injection.

Group Type: EXPERIMENTAL

JNJ-77474462

Intervention Type: DRUG

JNJ-77474462 will be administered as SC injection.

Placebo

Intervention Type: DRUG

Matching placebo to JNJ-77474462 will be administered as SC injection.

Interventions

JNJ-77474462

JNJ-77474462 will be administered as SC injection.

Intervention Type: DRUG

Placebo

Matching placebo to JNJ-77474462 will be administered as SC injection.

Intervention Type: DRUG

Other Intervention Names

Bermekimab

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Nucleus Network, Q-Pharm Pty Ltd

Herston, , Australia

Countries

Australia

Other Identifiers

77474462ADM1002

Identifier Type: OTHER

Identifier Source: secondary_id

CR108807

Identifier Type: -

Identifier Source: org_study_id