A Study of JNJ-73763989 in Healthy Japanese Adult Participants

Study Overview
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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).

Official Title
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A Double-blind, Placebo-controlled, Randomized, Parallel, Single Dose Study to Investigate Pharmacokinetics, Safety, and Tolerability of JNJ-73763989 in Healthy Japanese Adult Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: JNJ-73763989
* Drug: Placebo


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 20 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Panel A: JNJ-73763989 or Placebo<br>Participants will receive JNJ-73763989 (Dose Level 1) or matching placebo as single subcutaneous injection. | Drug: JNJ-73763989<br>* Participants will receive JNJ-73763989 as single subcutaneous injection.<br>Drug: Placebo<br>* Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.<br>|
| Experimental: Panel B: JNJ-73763989 or Placebo<br>Participants will receive JNJ-73763989 (Dose Level 2) or matching placebo as single subcutaneous injection. | Drug: JNJ-73763989<br>* Participants will receive JNJ-73763989 as single subcutaneous injection.<br>Drug: Placebo<br>* Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.<br>|
| Experimental: Panel C: JNJ-73763989 or Placebo<br>Participants will receive JNJ-73763989 (Dose Level 3) or matching placebo as single subcutaneous injection. | Drug: JNJ-73763989<br>* Participants will receive JNJ-73763989 as single subcutaneous injection.<br>Drug: Placebo<br>* Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 | Cmax is the maximum observed plasma analyte concentration. | Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 | Tmax is defined as actual sampling time to reach maximum observed plasma analyte concentration. | Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose | 
| Last Measurable Observed Plasma Concentration (Clast) of JNJ-73763989 | Clast is last measurable observed plasma analyte concentration. | Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose | 
| Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC[0-last]) of JNJ-73763989 | AUC(0-last) is area under the plasma concentration-time curve from time zero to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation. | Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose | 
| Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Up to 30 days after last study drug administration (Up to 7 weeks) |