A Phase 1, Randomized, Open-label, Parallel-group, Single- and Multiple-dose Study to Characterize Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of JNJ-70033093 (BMS-986177) in Healthy Chinese Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cohort A, B, C and D: Plasma Concentration of JNJ-70033093 After Multiple Dose Administration
研究概览
简要总结
The purpose of the study is to characterize the pharmacokinetics of single and multiple doses of JNJ-70033093 (BMS-986177) in healthy Chinese participants.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part 1: Cohort A: JNJ-70033093
Participants will receive Dose 1 of JNJ-70033093 once daily (QD) on Day 1 followed by washout period of 4 days and then Dose 1 of JNJ-70033093 QD from Days 5 to 12.
干预措施: JNJ-70033093 (Drug)
Part 1: Cohort B: JNJ-70033093
Participants will receive Dose 1 of JNJ-70033093 twice daily (BID) from Days 1 to 8.
干预措施: JNJ-70033093 (Drug)
Part 1: Cohort C: JNJ-70033093
Participants will receive Dose 2 of JNJ-70033093 BID from Days 1 to 8.
干预措施: JNJ-70033093 (Drug)
Part 2: Cohort D: JNJ-70033093
Participants will receive Dose 3 of JNJ-70033093 QD on Day 1 followed by washout period of 4 days and then Dose 3 of JNJ-70033093 BID from Days 5 to 12 in Cohort D. Dose escalation to Part 2: Cohort D will occur only after the safety and tolerability data of the Part 1 are assessed.
干预措施: JNJ-70033093 (Drug)
结局指标
主要结局
Cohort A, B, C and D: Plasma Concentration of JNJ-70033093 After Multiple Dose Administration
时间窗: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
Observed plasma concentration of JNJ-70033093 after multiple dose administration will be analyzed.
Cohort A and D: Plasma Concentration of JNJ-70033093 After Single Dose Administration
时间窗: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
Plasma concentration of JNJ-70033093 after single dose administration will be analyzed.
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Up to 54 Days)
- Number of Participants with Clinical Laboratory Abnormalities(Up to 54 Days)
- Percentage Change From Baseline in FXI Clotting Activity(Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B))
- Number of Participants with Vital Signs Abnormalities(Up to 54 Days)
- Change From Baseline in Activated Partial Thromboplastin Time (aPTT)(Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B))