NCT06631430已完成1 期
Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3810477 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
研究概览
简要总结
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3810477 in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 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 A: BI 3810477 formulation A dose group 1
Experimental
single dose group 1
干预措施: BI 3810477 (Drug)
Part A: BI 3810477 formulation A dose group 2
Experimental
single dose group 2
干预措施: BI 3810477 (Drug)
Part A: BI 3810477 formulation A dose group 3
Experimental
single dose group 3
干预措施: BI 3810477 (Drug)
Part A: BI 3810477 formulation A dose group 4
Experimental
single dose group 4
干预措施: BI 3810477 (Drug)
Part A: BI 3810477 formulation A dose group 5
Experimental
single dose group 5
干预措施: BI 3810477 (Drug)
Part A: BI 3810477 formulation A dose group 6
Experimental
single dose group 6
干预措施: BI 3810477 (Drug)
Part A: BI 3810477 formulation A dose group 7
Experimental
single dose group 7
干预措施: BI 3810477 (Drug)
Part B: BI 3810477 formulation B dose group 1
Experimental
single dose group 1
干预措施: BI 3810477 (Drug)
Part B: BI 3810477 formulation B dose group 2
Experimental
single dose group 2
干预措施: BI 3810477 (Drug)
Part B: BI 3810477 formulation B dose group 3
Experimental
single dose group 3
干预措施: BI 3810477 (Drug)
Part A and Part B_Placebo
Placebo Comparator
single dose of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
时间窗: Up to Day 85
次要结局
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(Up to Day 85)
- Maximum measured concentration of the analyte in plasma (Cmax)(Up to Day 85)
研究者
研究点 (1)
Loading locations...
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