NCT01650155已完成1 期
Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Intravenous and Subcutaneous Doses of BI 1005273 in Healthy Male Volunteers (Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)
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
- 88
- 试验地点
- 1
- 主要终点
- number (% subjects) with drug-related AEs.
研究概览
简要总结
To investigate the safety and tolerability of BI 1005273 in healthy male volunteers following intravenous (i.v.) infusion of single rising doses and subcutaneous (s.c.) injection. Secondary objectives are the exploration of the pharmacokinetics and early pharmacodynamics of BI 1005273.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 45 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 1005273 i.v.
Experimental
single dose i.v. infusion
干预措施: BI 1005273 i.v. (Drug)
BI 1005273 i.v. Placebo
Placebo Comparator
single dose i.v. infusion (Placebo)
干预措施: BI 105273 i.v. Placebo (Drug)
BI 1005273 s.c.
Experimental
single dose s.c. injection
干预措施: BI 1005273 s.c. (Drug)
BI 1005273 s.c. Placebo
Placebo Comparator
single dose s.c. injection (Placebo)
干预措施: BI 1005273 s.c. Placebo (Drug)
结局指标
主要结局
number (% subjects) with drug-related AEs.
时间窗: day -21 to day 95
次要结局
- Cmax (maximum measured concentration of the analyte in plasma)(day 1 to day 90)
- AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(day 1 to day 90)
- AUC0-tz (area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose)(day 1 to day 90)
研究者
研究点 (1)
Loading locations...
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