A Study of JNJ-73763989 in Healthy Chinese Adult Participants

Study Overview
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Brief Summary
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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).

Official Title
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A Randomized, Open-Label, Parallel, Single Dose Study to Investigate Pharmacokinetics, Safety, and Tolerability of JNJ-73763989 in Healthy Chinese Adult Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: JNJ-73763989


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 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. | Up to 4 Weeks | 
| Plasma Concentration of JNJ-73763989 | Plasma samples will be analyzed to determine concentrations of JNJ-73763989 (as the 2 triggers JNJ-73763976 and JNJ-73763924). | Predose up to 48 hours postdose (up to Day 3) | 
| Urine Concentration of JNJ-73763989 | Urine samples will be analyzed to determine concentrations of JNJ-73763989 (as the 2 triggers JNJ-73763976 and JNJ-73763924). | Predose up to 48 hours postdose (up to Day 3) |