A Study of JNJ-73763989 in Healthy Chinese Adult Participants
- Conditions
- Healthy
- Interventions
- Drug: JNJ-73763989
- Registration Number
- NCT04586439
- Lead Sponsor
- Janssen Research & Development, LLC
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Panel A: JNJ-73763989 JNJ-73763989 Participants will receive single subcutaneous (SC) injection of low dose of JNJ-73763989 on Day 1. Panel B: J NJ-73763989 JNJ-73763989 Participants will receive single SC injection of high dose of JNJ-73763989 on Day 1.
- Primary Outcome Measures
Name Time Method 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.
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).
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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Peking University Third Hospital
🇨🇳Beijing, China