A Double-blind, Placebo-controlled, Randomized, Parallel, Single Dose Study to Investigate Pharmacokinetics, Safety, and Tolerability of JNJ-73763989 in Healthy Japanese Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989
研究概览
简要总结
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).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Panel A: JNJ-73763989 or Placebo
Participants will receive JNJ-73763989 (Dose Level 1) or matching placebo as single subcutaneous injection.
干预措施: JNJ-73763989 (Drug)
Panel A: JNJ-73763989 or Placebo
Participants will receive JNJ-73763989 (Dose Level 1) or matching placebo as single subcutaneous injection.
干预措施: Placebo (Drug)
Panel B: JNJ-73763989 or Placebo
Participants will receive JNJ-73763989 (Dose Level 2) or matching placebo as single subcutaneous injection.
干预措施: JNJ-73763989 (Drug)
Panel B: JNJ-73763989 or Placebo
Participants will receive JNJ-73763989 (Dose Level 2) or matching placebo as single subcutaneous injection.
干预措施: Placebo (Drug)
Panel C: JNJ-73763989 or Placebo
Participants will receive JNJ-73763989 (Dose Level 3) or matching placebo as single subcutaneous injection.
干预措施: JNJ-73763989 (Drug)
Panel C: JNJ-73763989 or Placebo
Participants will receive JNJ-73763989 (Dose Level 3) or matching placebo as single subcutaneous injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点