Healthy
Conditions
Brief summary
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).
Interventions
DRUGJNJ-73763989
JNJ-73763989 will be administered (high or low dose) as single SC injection.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Up to 4 Weeks | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
| Plasma Concentration of JNJ-73763989 | Predose up to 48 hours postdose (up to Day 3) | Plasma samples will be analyzed to determine concentrations of JNJ-73763989 (as the 2 triggers JNJ-73763976 and JNJ-73763924). |
| Urine Concentration of JNJ-73763989 | Predose up to 48 hours postdose (up to Day 3) | Urine samples will be analyzed to determine concentrations of JNJ-73763989 (as the 2 triggers JNJ-73763976 and JNJ-73763924). |
Countries
China
Outcome results
None listed