A Study of JNJ-77474462 in Healthy Participants

NCT04544813 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10877177474462ADM1001
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

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

  Cmax is the maximum observed plasma concentration.

  Up to Week 12

• Area Under the Plasma Concentration Versus Time Curve from Time Zero to Infinity with Extrapolation of the Terminal Phase (AUC[0-infinity]) of JNJ-77474462

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

  Up to Week 12

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

  Up to Week 12

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

  T1/2 is defined as the time measured for the plasma concentration to decrease by 1 half of its original concentration.

  Up to Week 12

• Absolute Subcutaneous (SC) Bioavailability (F%)

  (F%) is defined as absolute SC bioavailability to be calculated using the following equation: AUC(0-infinity) SC/mean AUC(0-infinity) IV \* 100 percent (%).

  Up to Week 12

Secondary Outcomes (6)

• Percentage of Participants with Treatment-emergent Adverse Events (TEAE)

  Up to Week 12

• Percentage of Participants with Serious Adverse Events (SAE)

  Up to Week 12

• Number of Participants with Clinically Significant Changes in Vital Signs

  Up to Week 12

• Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG)

  Up to Week 12

• Number of Participants with Clinically Significant Changes in Laboratory Findings

  Up to Week 12

Study Arms (10)

Cohort A: JNJ-77474462 SC (Wave 1)

EXPERIMENTAL

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

Drug: JNJ-77474462

Cohort B: JNJ-77474462 SC (Wave 1)

EXPERIMENTAL

Participants will receive single dose of JNJ-77474462 SC.

Drug: JNJ-77474462

Cohort C: JNJ-77474462 SC (Wave 1)

EXPERIMENTAL

Participants will receive single dose of JNJ-77474462 SC.

Drug: JNJ-77474462

Cohort D: JNJ-77474462 SC (Wave 1)

EXPERIMENTAL

Participants will receive single dose of JNJ-77474462 SC.

Drug: JNJ-77474462

Cohort E: JNJ-77474462 IV (Wave 1)

EXPERIMENTAL

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

Drug: JNJ-77474462

Cohort F: JNJ-77474462 SC (Wave 2)

EXPERIMENTAL

Participants will receive single dose of JNJ-77474462 SC.

Drug: JNJ-77474462

Cohort G: JNJ-77474462 SC (Wave 2)

EXPERIMENTAL

Participants will receive single dose of JNJ-77474462 SC.

Drug: JNJ-77474462

Cohort H: JNJ-77474462 IV (Wave 2)

EXPERIMENTAL

Participants will receive single dose of JNJ-77474462 IV.

Drug: JNJ-77474462

Cohort I: JNJ-77474462 IV (Wave 2)

EXPERIMENTAL

Participants will receive single dose of JNJ-77474462 IV.

Drug: JNJ-77474462

Cohort J: Anakinra SC

ACTIVE COMPARATOR

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

Drug: Anakinra

Interventions

JNJ-77474462 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).

Also known as: Bermekimab

Cohort A: JNJ-77474462 SC (Wave 1); Cohort B: JNJ-77474462 SC (Wave 1); Cohort C: JNJ-77474462 SC (Wave 1); Cohort D: JNJ-77474462 SC (Wave 1); Cohort E: JNJ-77474462 IV (Wave 1); Cohort F: JNJ-77474462 SC (Wave 2); Cohort G: JNJ-77474462 SC (Wave 2); Cohort H: JNJ-77474462 IV (Wave 2); Cohort I: JNJ-77474462 IV (Wave 2)

Anakinra DRUG

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

Cohort J: Anakinra SC

Eligibility Criteria

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

You may qualify if:

• 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

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, 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Nucleus Network, Q-Pharm Pty Ltd

Herston, 4006, Australia

Location

MeSH Terms

Interventions

bermekimab; Interleukin 1 Receptor Antagonist Protein

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 10, 2020
• Study Start: October 13, 2020
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)