NCT02696616已完成1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 655088 Administered by Intravenous Infusion in Healthy Male Subjects (Single-blind, Partially Randomised Within Dose Groups, 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
- 47
- 试验地点
- 1
- 主要终点
- Number of Subjects With Drug-related Adverse Events
研究概览
简要总结
Investigation of safety and tolerability of BI 655088 following intravenous infusion of single rising doses and exploration of the pharmacokinetics and pharmacodynamics of BI 655088 after single dosing
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 50 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
BI 655088
Experimental
干预措施: BI 655088 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects With Drug-related Adverse Events
时间窗: up to 99 days after start of drug administration
The number of subjects with drug-related adverse events.
次要结局
- Maximum Measured Concentration of BI 655088 in Plasma (Cmax)(Up to 2016 hours. See endpoint description for a detailed timeframe.)
- Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)(Up to 2016 hours. See endpoint description for a detailed timeframe.)
- Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)(Up to 2016 hours. See endpoint description for a detailed timeframe.)
研究者
研究点 (1)
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