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

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT04712006
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: JNJ-64304500	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Anticipated Study Start Date: May 30, 2021
• Anticipated Primary Completion Date: Aug 27, 2021
• Anticipated Study Completion Date: Oct 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Serum Concentration of JNJ-64304500 [Up to Day 113]

   Serum samples will be analyzed to determine concentrations of JNJ-64304500 using a validated, specific and sensitive immunoassay method.

Secondary Outcome Measures

1. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [Up to Day 113]

   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.

2. Number of Participants with Antibodies to JNJ-64304500 [Up to Day 113]

   Number of participants with antibodies to JNJ-64304500 will be reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Third Hospital	Beijing		China	100089

Sponsors and Collaborators

• Janssen Research & Development, LLC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT04712006
• Other Study ID Numbers: CR108840; 64304500CRD1003
• First Posted: Jan 15, 2021
• Last Update Posted: Sep 1, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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

Study Results

No Results Posted as of Sep 1, 2021