A Study to Compare Two Different Subcutaneously-administered JNJ-64304500 Formulations in Healthy Participants

NCT04667052 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR10879664304500CRD10022020-003559-14
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the relative bioavailability of JNJ-64304500 after administration of two different formulations in healthy participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Serum Concentration (Cmax) of JNJ-64304500

  Cmax is the maximum observed serum concentration.

  Up to Day 113

• Area Under the Serum Concentration - Time Curve From Time Zero to Time Infinity (AUC [0-infinity]) of JNJ-64304500

  AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinity time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the serum concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable concentration, and lambda(z) is apparent terminal elimination rate constant.

  Up to Day 113

Secondary Outcomes (5)

• Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  Up to Day 113

• Number of Participants with Clinically Significant Abnormalities in Vital Signs

  Up to Day 113

• Number of Participants with Clinically Significant Abnormalities in Physical Examinations

  Up to Day 113

• Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters

  Up to Day 113

• Number of Participants with Serum Antibodies to JNJ-64304500

  Up to Day 113

Study Arms (2)

JNJ 64304500: Reference

EXPERIMENTAL

Participants (including individuals of Han Chinese background) will be randomized to receive a single subcutaneous dose of JNJ-64304500 reference formulation.

Drug: JNJ 64304500

JNJ 64304500: Test

EXPERIMENTAL

Participants (including individuals of Han Chinese background) will be randomized to receive a single subcutaneous dose of JNJ-64304500 test formulation.

Drug: JNJ 64304500

Interventions

JNJ 64304500 DRUG

Participants will receive a single subcutaneous dose of JNJ-64304500 reference formulation.

JNJ 64304500: Reference

Eligibility Criteria

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

You may qualify if:

• Male or non-childbearing potential female (according to their reproductive organs and functions assigned by chromosomal complement)
• For Han Chinese participants, they need to have resided outside of China for no more than 10 years and have parents and maternal and paternal grandparents who are of Han Chinese ethnicity
• Have a body weight in the range of 60 kilograms (kg) to 90 kg and within a body mass index range between 18 and 30 kilogram per square meters (kg/m\^2), inclusive
• Healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening.
• Healthy on the basis of clinical laboratory tests performed at screening.

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) liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
• Has a QT corrected according to Fridericia's formula (QTcF) interval greater than (\>) 450 milliseconds (msec) for males, and \>470 msec for females, has a complete left or right bundle branch block, or has a history or current evidence of additional risk factors for torsades de pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome) at screening and at predose (Day -1)
• Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
• Had major illness or surgery, (for example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from illness or surgery, or has surgery planned during the time the participant is expected to participate in the study or until Day 113 (Participants who had minor surgical procedures conducted under local anesthesia within 4 weeks before screening may participate)
• Plans to undergo non-major elective surgery within 4 weeks prior to study intervention administration through the end of the study

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

WCCT Global, LLC

Cypress, California, 90630, United States

Location

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 14, 2020
• Study Start: January 13, 2021
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)