A Study of JNJ-73763989 in Healthy Japanese 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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-04

Study Completion Date

2019-08-23

Brief Summary

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The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of JNJ-73763989 in healthy Japanese adult participants following single-dose subcutaneous administration of 3 different doses of JNJ-73763989, Dose Level 1 (Panel A), Dose Level 2 (Panel B) or Dose Level 3 (Panel C).

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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

DOUBLE

Participants Investigators

Study Groups

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Panel A: JNJ-73763989 or Placebo

Participants will receive JNJ-73763989 (Dose Level 1) or matching placebo as single subcutaneous injection.

Group Type EXPERIMENTAL

JNJ-73763989

Intervention Type DRUG

Participants will receive JNJ-73763989 as single subcutaneous injection.

Placebo

Intervention Type DRUG

Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.

Panel B: JNJ-73763989 or Placebo

Participants will receive JNJ-73763989 (Dose Level 2) or matching placebo as single subcutaneous injection.

Group Type EXPERIMENTAL

JNJ-73763989

Intervention Type DRUG

Participants will receive JNJ-73763989 as single subcutaneous injection.

Placebo

Intervention Type DRUG

Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.

Panel C: JNJ-73763989 or Placebo

Participants will receive JNJ-73763989 (Dose Level 3) or matching placebo as single subcutaneous injection.

Group Type EXPERIMENTAL

JNJ-73763989

Intervention Type DRUG

Participants will receive JNJ-73763989 as single subcutaneous injection.

Placebo

Intervention Type DRUG

Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.

Interventions

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JNJ-73763989

Participants will receive JNJ-73763989 as single subcutaneous injection.

Intervention Type DRUG

Placebo

Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participant must be a Japanese participant who has resided outside Japan for no more than 10 years and whose parents and grandparents are Japanese, as determined by participant's verbal report
* Participant must have a body mass index (BMI; weight in kilogram \[kg\] divided by the square of height in meters) of 18.0 to 30.0 kilogram per square meter (kg/m\^2) extremes included, and body weight not less than 45.0 kg

Exclusion Criteria

* A female participant of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) 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 until at least 90 days after receiving the study drug

* Participant with a history of cardiac arrhythmias (for example, premature ventricular contractions), history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia, family history of long QT Syndrome)
* Female participant who is pregnant, breast-feeding, or planning to become pregnant during the study or within 90 days after receiving the study drug (or longer, if dictated by local regulation)
* Male participants who plan to father a child during the study or within 90 days after receiving the study drug (or longer, if dictated by local regulation)
* Participant with human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2) 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 Hepatitis B surface antigen \[HBsAg\]), or hepatitis C virus (HCV) infection (confirmed by HCV antibody), or hepatitis E infection (confirmed by hepatitis E antibody IgM) at screening

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes