A Study of JNJ-77474462 in Healthy Participants

NCT ID: NCT04544813

Last Updated: 2023-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-13
• Study Completion Date: 2021-05-30

Brief Summary

The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-77474462 after single subcutaneous (SC) or intravenous (IV) administrations and the effect of formulation concentrations on PK of JNJ-77474462 in healthy participants.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cohort A: JNJ-77474462 SC (Wave 1)

Participants will receive single dose of JNJ-77474462 subcutaneously (SC).

Group Type: EXPERIMENTAL

JNJ-77474462

Intervention Type: DRUG

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).

Cohort B: JNJ-77474462 SC (Wave 1)

Participants will receive single dose of JNJ-77474462 SC.

Group Type: EXPERIMENTAL

JNJ-77474462

Intervention Type: DRUG

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).

Cohort C: JNJ-77474462 SC (Wave 1)

Participants will receive single dose of JNJ-77474462 SC.

Group Type: EXPERIMENTAL

JNJ-77474462

Intervention Type: DRUG

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).

Cohort D: JNJ-77474462 SC (Wave 1)

Participants will receive single dose of JNJ-77474462 SC.

Group Type: EXPERIMENTAL

JNJ-77474462

Intervention Type: DRUG

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).

Cohort E: JNJ-77474462 IV (Wave 1)

Participants will receive single dose of JNJ-77474462 intravenously (IV).

Group Type: EXPERIMENTAL

JNJ-77474462

Intervention Type: DRUG

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).

Cohort F: JNJ-77474462 SC (Wave 2)

Participants will receive single dose of JNJ-77474462 SC.

Group Type: EXPERIMENTAL

JNJ-77474462

Intervention Type: DRUG

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).

Cohort G: JNJ-77474462 SC (Wave 2)

Participants will receive single dose of JNJ-77474462 SC.

Group Type: EXPERIMENTAL

JNJ-77474462

Intervention Type: DRUG

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).

Cohort H: JNJ-77474462 IV (Wave 2)

Participants will receive single dose of JNJ-77474462 IV.

Group Type: EXPERIMENTAL

JNJ-77474462

Intervention Type: DRUG

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).

Cohort I: JNJ-77474462 IV (Wave 2)

Participants will receive single dose of JNJ-77474462 IV.

Group Type: EXPERIMENTAL

JNJ-77474462

Intervention Type: DRUG

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).

Cohort J: Anakinra SC

Participants will receive a SC injection of anakinra once daily for 3 days.

Group Type: ACTIVE_COMPARATOR

Anakinra

Intervention Type: DRUG

Participants will receive a SC injection of anakinra 100 mg once daily for 3 days.

Interventions

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).

Intervention Type: DRUG

Anakinra

Participants will receive a SC injection of anakinra 100 mg once daily for 3 days.

Intervention Type: DRUG

Other Intervention Names

Bermekimab

Eligibility Criteria

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

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

• 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

77474462ADM1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108771

Identifier Type: -

Identifier Source: org_study_id