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

NCT04712006 | Withdrawn Phase 1

• 2 other identifiers: CR10884064304500CRD1003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

  Up to Day 113

• Number of Participants with Antibodies to JNJ-64304500

  Up to Day 113

Study Arms (2)

Cohort 1: JNJ-64304500

EXPERIMENTAL

Participants will receive single subcutaneous (SC) Dose 1 of JNJ-64304500 on Day 1.

Drug: JNJ-64304500

Cohort 2: JNJ-64304500

EXPERIMENTAL

Participants will receive single SC Dose 2 of JNJ-64304500 on Day 1.

Drug: JNJ-64304500

Interventions

JNJ-64304500 DRUG

Participants will be administered with JNJ-64304500 SC (Dose 1 or 2) injection on Day 1.

Cohort 1: JNJ-64304500; Cohort 2: JNJ-64304500

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100089, China

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 15, 2021
• Study Start: May 30, 2021
• Primary Completion: August 27, 2021
• Study Completion: October 30, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)