A Study of JNJ-64304500 Following Subcutaneous Injection in Healthy Chinese Adult Participants

Phase 1, Open-label, Single Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of JNJ-64304500 Following Subcutaneous Injection in Healthy Chinese Adult Participants

The purpose of this study is to assess the pharmacokinetic following single subcutaneous administration of Dose 1 or Dose 2 of JNJ-64304500 in healthy Chinese adult participants.

Study Overview

• Status: Withdrawn
• Conditions: Healthy
• Intervention / Treatment: Drug: JNJ-64304500

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100089
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female Chinese participants whose parents and maternal and paternal grandparents are of Chinese ethnicity
• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and until Day 113
• A male participant must agree not to donate sperm for the purpose of reproduction and must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and until Day 113
• A woman must have a negative highly sensitive serum beta-human chorionic gonadotropin (hCG) at screening and a negative urine pregnancy test on Day -1 and while enrolled in this study
• Nonsmoker or agree to smoke no more than 10 cigarettes or equivalent of e-cigarettes, or 2 cigars, or 2 pipes of tobacco per day throughout the study, if the inpatient unit allows. However, if smoking is not allowed in the inpatient unit, smokers will not be allowed to smoke while inpatient and cannot use nicotine replacement products during the inpatient period

Exclusion Criteria:

• History of any clinically significant medical illness or medical disorders the investigator considers should be 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
• Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
• Had major illness or surgery, (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
• Plans to undergo non-major elective surgery within 4 weeks prior to study intervention administration through the end of the study
• Known or suspected allergies, hypersensitivity or intolerance to JNJ-64304500 or any biologic medication, or known allergies or clinically significant reactions to murine, chimeric, or human proteins, mAbs or antibody fragments, or to any components of the formulation of JNJ-64304500 and its excipients used in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: JNJ-64304500; Participants will receive single subcutaneous (SC) Dose 1 of JNJ-64304500 on Day 1.	Drug: JNJ-64304500; Participants will be administered with JNJ-64304500 SC (Dose 1 or 2) injection on Day 1.
Experimental: Cohort 2: JNJ-64304500; Participants will receive single SC Dose 2 of JNJ-64304500 on Day 1.	Drug: JNJ-64304500; Participants will be administered with JNJ-64304500 SC (Dose 1 or 2) injection on Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Concentration of JNJ-64304500	Serum samples will be analyzed to determine concentrations of JNJ-64304500 using a validated, specific and sensitive immunoassay method.	Up to Day 113

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.	Up to Day 113
Number of Participants with Antibodies to JNJ-64304500	Number of participants with antibodies to JNJ-64304500 will be reported.	Up to Day 113

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Anticipated): May 30, 2021
• Primary Completion (Anticipated): August 27, 2021
• Study Completion (Anticipated): October 30, 2021

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CR108840; 64304500CRD1003 (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 and 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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No