A Study of JNJ-77474462 in Healthy Participants

A Phase 1 Study to Investigate the Pharmacokinetics and Pharmacodynamics of JNJ-77474462 in Healthy Participants

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 78
• 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: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: JNJ-77474462 SC (Wave 1); Participants will receive single dose of JNJ-77474462 subcutaneously (SC).	Drug: 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).; Other Names: Bermekimab
Experimental: Cohort B: JNJ-77474462 SC (Wave 1); Participants will receive single dose of JNJ-77474462 SC.	Drug: 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).; Other Names: Bermekimab
Experimental: Cohort C: JNJ-77474462 SC (Wave 1); Participants will receive single dose of JNJ-77474462 SC.	Drug: 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).; Other Names: Bermekimab
Experimental: Cohort D: JNJ-77474462 SC (Wave 1); Participants will receive single dose of JNJ-77474462 SC.	Drug: 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).; Other Names: Bermekimab
Experimental: Cohort E: JNJ-77474462 IV (Wave 1); Participants will receive single dose of JNJ-77474462 intravenously (IV).	Drug: 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).; Other Names: Bermekimab
Experimental: Cohort F: JNJ-77474462 SC (Wave 2); Participants will receive single dose of JNJ-77474462 SC.	Drug: 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).; Other Names: Bermekimab
Experimental: Cohort G: JNJ-77474462 SC (Wave 2); Participants will receive single dose of JNJ-77474462 SC.	Drug: 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).; Other Names: Bermekimab
Experimental: Cohort H: JNJ-77474462 IV (Wave 2); Participants will receive single dose of JNJ-77474462 IV.	Drug: 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).; Other Names: Bermekimab
Experimental: Cohort I: JNJ-77474462 IV (Wave 2); Participants will receive single dose of JNJ-77474462 IV.	Drug: 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).; Other Names: Bermekimab
Active Comparator: Cohort J: Anakinra SC; Participants will receive a SC injection of anakinra once daily for 3 days.	Drug: Anakinra; Participants will receive a SC injection of anakinra 100 mg once daily for 3 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Treatment-emergent Adverse Events (TEAE)	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 adverse events (AEs) with onset or worsening on or after date of first dose of study treatment.	Up to Week 12
Percentage of Participants with Serious Adverse Events (SAE)	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 12
Number of Participants with Clinically Significant Changes in Vital Signs	Number of participants with clinically significant changes in vital signs (including body temperature, resting [supine] pulse/heart rate, respiratory rate and blood pressure) will be reported.	Up to Week 12
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG)	Number of participants with clinically significant changes ECG will be reported.	Up to Week 12
Number of Participants with Clinically Significant Changes in Laboratory Findings	Number of participants with clinically significant changes in laboratory findings (that is, hematology, clinical chemistry, urinalysis) will be reported.	Up to Week 12
Number of Participants with Anti-JNJ-77474462 Antibodies	Number of participants with anti-drug antibodies to JNJ-77474462 will be reported.	Up to Week 12

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2020
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): May 30, 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): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antirheumatic Agents; Interleukin 1 Receptor Antagonist Protein
• Other Study ID Numbers: CR108771; 77474462ADM1001 (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