A Study of JNJ-73763989 in Healthy Japanese Adult Participants

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: JNJ-73763989

Study type: Interventional

Funder types: Industry

Identifiers

NCT04002752

73763989HPB1001 (Other Identifier)

2019-000629-31 (EudraCT Number)

CR108646

Details and patient eligibility

About

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).

Enrollment: 25 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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
• Participant must be healthy on the basis of physical examination, clinical laboratory tests, medical history, and vital signs performed at screening. In case of abnormalities (except for those listed in the exclusion criteria) a participant may be included after all if the investigator judges the abnormalities not clinically significant or appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 3 patient groups

Panel A: JNJ-73763989 or Placebo

Experimental group

Description:

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

Treatment:

Drug: JNJ-73763989

Drug: Placebo

Panel B: JNJ-73763989 or Placebo

Experimental group

Description:

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

Treatment:

Drug: JNJ-73763989

Drug: Placebo

Panel C: JNJ-73763989 or Placebo

Experimental group

Description:

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

Treatment:

Drug: JNJ-73763989

Drug: Placebo