Safety, Tolerability, and Pharmacokinetics of Single Rising s.c. (Stage 1) and i.v. (Stage 2) Doses of BI 655066/ABBV-066 (Risankizumab) in Healthy Asian and Caucasian Male Volunteers (Double-blind, Randomized, Placebo-controlled Within Dose Groups)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percentage of subjects with drug-related adverse events
研究概览
简要总结
Safety, tolerability and pharmacokinetics of single dose of BI 655066/ABBV-066 (risankizumab) in healthy Chinese, Japanese and Caucasian male volunteers.
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, Investigator)
入排标准
- 年龄范围
- 20 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
Placebo IV (Stage2)
Placebo administered by intraveneous (IV) infusion
干预措施: Placebo (Drug)
Stage 2 (high dose IV)
High dose administered by intraveneous (IV) infusion
干预措施: ABBV-066 (Drug)
Placebo SC (Stage1)
Placebo administered by subcutaneous (SC) injection
干预措施: Placebo (Drug)
Stage 1 (low dose SC)
Low dose administered by subcutaneous (SC) injection
干预措施: ABBV-066 (Drug)
Stage 1 (medium dose SC)
Medium dose administered by subcutaneous (SC) injection
干预措施: ABBV-066 (Drug)
Stage 1 (high dose SC)
High dose administered by subcutaneous (SC) injection
干预措施: ABBV-066 (Drug)
Stage 2 (low dose IV)
Low dose administered by intraveneous (IV) infusion
干预措施: ABBV-066 (Drug)
Stage 2 (medium dose IV)
Medium dose administered by intraveneous (IV) infusion
干预措施: ABBV-066 (Drug)
结局指标
主要结局
Percentage of subjects with drug-related adverse events
时间窗: Up to 144 days after screening
次要结局
- Time from dosing to the maximum plasma concentration of the analyte in plasma (tmax)(Up to 144 days after randomization)
- Terminal half-life of the analyte in plasma (t1/2)(Up to 144 days after randomization)
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to time of the last quantifiable plasma concentration (AUC0-tz)(Up to 144 days after randomization)
- Maximum measured plasma concentration of the analyte in plasma (Cmax)(Up to 144 days after randomization)
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)(Up to 144 days after randomization)