NCT06232252已完成1 期
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Intravenous Doses of BI 765423 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
- 38
- 试验地点
- 1
- 主要终点
- Percentage of subjects treated with BI 765423 who experience 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 of BI 765423 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
- Double (Participant, Outcomes Assessor)
盲法说明
Participant: This trial is blinded to treatment but not to dose level. The dose level will be known to the participant.
Outcome assessor: ECG laboratory
入排标准
- 年龄范围
- 18 Years 至 55 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
Dose group (DG) 3 (medium dose)
Experimental
干预措施: Placebo matching BI 765423 (Drug)
Dose group (DG) 4 (high dose)
Experimental
干预措施: BI 765423 (Drug)
Dose group (DG) 1 (very low dose)
Experimental
干预措施: BI 765423 (Drug)
Dose group (DG) 1 (very low dose)
Experimental
干预措施: Placebo matching BI 765423 (Drug)
Dose group (DG) 2 (low dose)
Experimental
干预措施: BI 765423 (Drug)
Dose group (DG) 2 (low dose)
Experimental
干预措施: Placebo matching BI 765423 (Drug)
Dose group (DG) 3 (medium dose)
Experimental
干预措施: BI 765423 (Drug)
Dose group (DG) 4 (high dose)
Experimental
干预措施: Placebo matching BI 765423 (Drug)
结局指标
主要结局
Percentage of subjects treated with BI 765423 who experience any treatment-emergent adverse event assessed as drug-related by the investigator
时间窗: up to 145 days for DG 1 and 2, up to 159 days for DG 3 and 4
次要结局
- AUCτ (area under the concentration-time curve of the analyte in serum over a uniform dosing interval τ)(up to 336 hours for DG 1 and 2, up to 673 hours for DG 3 and 4)
- Cmax (maximum measured concentration of the analyte in serum)(up to 141 days for DG 1 and 2, up to 155 days for DG 3 and 4)
研究者
研究点 (1)
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