A Study of JNJ-73763989 in Healthy Japanese Adult Participants
- Registration Number
- NCT04002752
- Lead Sponsor
- Janssen Sciences Ireland UC
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Panel C: JNJ-73763989 or Placebo Placebo Participants will receive JNJ-73763989 (Dose Level 3) or matching placebo as single subcutaneous injection. Panel A: JNJ-73763989 or Placebo Placebo Participants will receive JNJ-73763989 (Dose Level 1) or matching placebo as single subcutaneous injection. Panel C: JNJ-73763989 or Placebo JNJ-73763989 Participants will receive JNJ-73763989 (Dose Level 3) or matching placebo as single subcutaneous injection. Panel B: JNJ-73763989 or Placebo Placebo Participants will receive JNJ-73763989 (Dose Level 2) or matching placebo as single subcutaneous injection. Panel A: JNJ-73763989 or Placebo JNJ-73763989 Participants will receive JNJ-73763989 (Dose Level 1) or matching placebo as single subcutaneous injection. Panel B: JNJ-73763989 or Placebo JNJ-73763989 Participants will receive JNJ-73763989 (Dose Level 2) or matching placebo as single subcutaneous injection.
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose Cmax is the maximum observed plasma analyte concentration.
Last Measurable Observed Plasma Concentration (Clast) of JNJ-73763989 Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose Clast is last measurable observed plasma analyte concentration.
Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC[0-last]) of JNJ-73763989 Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose 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.
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability Up to 30 days after last study drug administration (Up to 7 weeks) AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose Tmax is defined as actual sampling time to reach maximum observed plasma analyte concentration.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PAREXEL International
🇬🇧London, United Kingdom