A Study of JNJ-73763989 in Healthy Chinese Adult Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-24

Study Completion Date

2021-02-18

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).

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Panel A: JNJ-73763989

Participants will receive single subcutaneous (SC) injection of low dose of JNJ-73763989 on Day 1.

Group Type EXPERIMENTAL

JNJ-73763989

Intervention Type DRUG

JNJ-73763989 will be administered (high or low dose) as single SC injection.

Panel B: J NJ-73763989

Participants will receive single SC injection of high dose of JNJ-73763989 on Day 1.

Group Type EXPERIMENTAL

JNJ-73763989

Intervention Type DRUG

JNJ-73763989 will be administered (high or low dose) as single SC injection.

Interventions

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JNJ-73763989

JNJ-73763989 will be administered (high or low dose) as single SC injection.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes