NCT01958060终止1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Intravenous and Subcutaneous Doses of BI 1034020 in Healthy Male Volunteers (Partially 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
- 终止
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Percentage of Subjects With Drug Related Adverse Events
研究概览
简要总结
Investigation of safety and tolerability of BI 1034020 in healthy male volunteers following intravenous (IV) infusion of subcutaneous (SC) injection of single doses and exploration of the pharmacokinetics and pharmacodynamics of BI 1034020 after single dosing and determination of the bioavailability of subcutaneous injections of BI 1034020
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 40 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 1034020 subcutaneous part
Experimental
single rising doses
干预措施: BI 1034020 (Drug)
BI 1034020 subcutaneous part
Experimental
single rising doses
干预措施: Placebo to BI 1034020 (Drug)
BI 1034020 intravenous part
Experimental
single rising doses
干预措施: BI 1034020 (Drug)
BI 1034020 intravenous part
Experimental
single rising doses
干预措施: Placebo to BI 1034020 (Drug)
结局指标
主要结局
Percentage of Subjects With Drug Related Adverse Events
时间窗: from the first drug administration to end of trial, up to 50 days
Percentage of subjects with investigator defined drug-related adverse events
次要结局
- Cmax(2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.)
- AUC0-inf(2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.)
- AUC0-tz(2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.)
研究者
研究点 (2)
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