A Randomized, Open-Label, Parallel, Single Dose Study to Investigate Pharmacokinetics, Safety, and Tolerability of JNJ-73763989 in Healthy Chinese Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Panel A: JNJ-73763989
Participants will receive single subcutaneous (SC) injection of low dose of JNJ-73763989 on Day 1.
干预措施: JNJ-73763989 (Drug)
Panel B: J NJ-73763989
Participants will receive single SC injection of high dose of JNJ-73763989 on Day 1.
干预措施: JNJ-73763989 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
未报告次要终点