A Study of JNJ-73763989 in Healthy Chinese Adult Participants

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04586439
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.8
• Patients Per Site Per Month: 6.4

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the single-dose Pharmacokinetics of JNJ-73763976 and JNJ-73763924 following a subcutaneous (SC) injection of JNJ-73763989 (JNJ-3989) in healthy Chinese adult participants at 2 different doses, Dose 1 (Panel A) or Dose 2 (Panel B).

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: JNJ-73763989	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Randomized, Open-Label, Parallel, Single Dose Study to Investigate Pharmacokinetics, Safety, and Tolerability of JNJ-73763989 in Healthy Chinese Adult Participants
• Actual Study Start Date: Nov 24, 2020
• Actual Primary Completion Date: Feb 18, 2021
• Actual Study Completion Date: Feb 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Panel A: JNJ-73763989 Participants will receive single subcutaneous (SC) injection of low dose of JNJ-73763989 on Day 1.	Drug: JNJ-73763989; JNJ-73763989 will be administered (high or low dose) as single SC injection.
Experimental: Panel B: J NJ-73763989 Participants will receive single SC injection of high dose of JNJ-73763989 on Day 1.	Drug: JNJ-73763989; JNJ-73763989 will be administered (high or low dose) as single SC injection.

Outcome Measures

Primary Outcome Measures

1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Up to 4 Weeks]

   An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

2. Plasma Concentration of JNJ-73763989 [Predose up to 48 hours postdose (up to Day 3)]

   Plasma samples will be analyzed to determine concentrations of JNJ-73763989 (as the 2 triggers JNJ-73763976 and JNJ-73763924).

3. Urine Concentration of JNJ-73763989 [Predose up to 48 hours postdose (up to Day 3)]

   Urine samples will be analyzed to determine concentrations of JNJ-73763989 (as the 2 triggers JNJ-73763976 and JNJ-73763924).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Participant must be healthy based on physical examination, laboratory assessment, vital signs and electrocardiogram (ECG) at screening

• A female participant of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [hCG]) pregnancy test at screening and a negative urine pregnancy test on Day -1

• A male participant must agree not to donate sperm after enrollment (Day 1) in the study and a female participant must agree not to donate eggs (ova, oocytes) during the study until at least 90 days after receiving the study drug

• Participant must not use nicotine-containing substances including tobacco products for at least 3 months prior to screening until completion of the study

• Participant must have suitable veins for cannulation and/or repeated venipuncture

Exclusion Criteria:

• Participant with a history of cardiac arrhythmias (example, premature ventricular contractions), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)

• Participant with human immunodeficiency virus infection (confirmed by antibodies) at screening

• Participant with current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), or hepatitis B infection (confirmed by HBsAg), or hepatitis C virus (HCV) infection (confirmed by HCV antibody), or hepatitis E infection (confirmed by hepatitis E antibody IgM) at screening

• Participant has positive test result(s) for alcohol and/or drugs of abuse (including amphetamines, benzodiazepines, cocaine, cannabinoids, opioids, and methadone) at screening and Day-1

• Participant has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit, or confound the protocol-specified assessments. This may include but is not limited to renal dysfunction estimated Glomerular Filtration Rate (GFR) <60 millimeter per minute (mL/min) /1.73 m^2 at screening

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: NCT04586439
• Other Study ID Numbers: CR108867; 73763989HPB1004
• First Posted: Oct 14, 2020
• Last Update Posted: Mar 8, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

No Results Posted as of Mar 8, 2021