Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses (0.2 mg to 120 mg Administered by Intravenous Infusion and 40 mg to 120 mg Administered by Subcutaneous Injection) of BI 655064 (Buffer Solution for Injection) in Healthy Male Volunteers (Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Changes in vital signs (blood pressure [BP], pulse rate [PR])
研究概览
简要总结
To investigate safety and tolerability of BI 655064 in healthy male volunteers following intravenous infusion of escalating single doses and following subcutaneous injection. Exploration of the pharmacokinetics and pharmacodynamics of BI 655064 after single dosing and determination of the bioavailability of subcutaneous injections of BI 655064.
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 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
BI 655064 subcutaneous
Escalating single dose as solution for subcutaneous injection
干预措施: BI 655064 (Drug)
Placebo to BI 655064 subcutaneous
Escalation single dose as solution for subcutaneous injection (Placebo)
干预措施: Placebo to BI 655064 (Drug)
BI 655064 intravenous
Escalating single dose as solution for intravenous infusion
干预措施: BI 655064 (Drug)
Placebo to BI 655064 intravenous
Escalating single dose as solution for intravenous infusion (Placebo)
干预措施: Placebo to BI 655064 (Drug)
结局指标
主要结局
Changes in vital signs (blood pressure [BP], pulse rate [PR])
时间窗: up to 70 days post treatment
Changes in 12-lead ECG (electrocardiogram)
时间窗: up to 70 days post treatment
Assessment of local tolerability by investigator
时间窗: up to 70 days post treatment
Incidence of adverse events
时间窗: up to 70 days post treatment
Assessment of global tolerability by investigator
时间窗: up to 70 days post treatment
次要结局
- Maximum measured concentration of the analyte in plasma(up to 1656 hours post treatment)
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity(up to 1656 hours post treatment)
- 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(up to 1656 hours post treatment)