Safety, Tolerability and Pharmacokinetics Study of Single Rising Doses of AbGn-168H Administered by Intravenous Infusion (125 μg/kg, 500 μg/kg, 1 mg/kg, 2 mg/kg) or Subcutaneous Injection (125 μg/kg, 1 mg/kg) to Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Safety and tolerability will be assessed in a descriptive way based on: Physical examination, vital sign, 12-lead ECG, clinical laboratory tests, adverse events, assessment of tolerability by investigator
研究概览
简要总结
The aim of the study is to investigate safety, tolerability and pharmacokinetics of single rising doses of AbGn-168H administered by intravenous infusion or subcutaneous injection to healthy male volunteers.
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
- Double
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
AbGn-168H very low dose i.v.
subject to receive a single very low dose of AbGn-168H intravenously (i.v.) or placebo
干预措施: Placebo (Drug)
AbGn-168H very low dose i.v.
subject to receive a single very low dose of AbGn-168H intravenously (i.v.) or placebo
干预措施: AbGn-168H (Drug)
AbGn-168H low dose i.v.
subject to receive a single low dose of AbGn-168H intravenously (i.v.) or placebo
干预措施: AbGn-168H (Drug)
AbGn-168H low dose i.v.
subject to receive a single low dose of AbGn-168H intravenously (i.v.) or placebo
干预措施: Placebo (Drug)
AbGn-168H medium dose i.v.
subject to receive a single medium dose of AbGn-168H intravenously (i.v.) or placebo
干预措施: Placebo (Drug)
AbGn-168H medium dose i.v.
subject to receive a single medium dose of AbGn-168H intravenously (i.v.) or placebo
干预措施: AbGn-168H (Drug)
AbGn-168H high dose i.v.
subject to receive a single high dose of AbGn-168H intravenously (i.v.) or placebo
干预措施: Placebo (Drug)
AbGn-168H very low dose s.c.
subject to receive a single very low dose of AbGn-168H subcutaneously (s.c.) or placebo
干预措施: Placebo (Drug)
AbGn-168H high dose i.v.
subject to receive a single high dose of AbGn-168H intravenously (i.v.) or placebo
干预措施: AbGn-168H (Drug)
AbGn-168H very low dose s.c.
subject to receive a single very low dose of AbGn-168H subcutaneously (s.c.) or placebo
干预措施: AbGn-168H (Drug)
AbGn-168H medium dose s.c.
subject to receive a single medium dose dose of AbGn-168H subcutaneously (s.c.) or placebo
干预措施: Placebo (Drug)
AbGn-168H medium dose s.c.
subject to receive a single medium dose dose of AbGn-168H subcutaneously (s.c.) or placebo
干预措施: AbGn-168H (Drug)
结局指标
主要结局
Safety and tolerability will be assessed in a descriptive way based on: Physical examination, vital sign, 12-lead ECG, clinical laboratory tests, adverse events, assessment of tolerability by investigator
时间窗: 6 weeks
次要结局
- MRT iv (mean residence time of the analyte in the body after intravenous injection or infusion)(6 weeks)
- MRT sc (mean residence time of the analyte in the body after subcutaneous injection)(6 weeks)
- CL (total/apparent clearance of the analyte in plasma after intravascular administration)(6 weeks)
- CL/F (apparent clearance of the analyte in plasma after extravascular administration)(6 weeks)
- V z (apparent volume of distribution during the terminal phase delta z following an intravascular dose)(6 weeks)
- V z/F (apparent volume of distribution during the terminal phase delta z after extravascular administration)(6 weeks)
- V ss (apparent volume of distribution at steady state following intravascular administration)(6 weeks)
- C max (maximum measured concentration of the analyte in plasma)(6 weeks)
- t max (time from dosing to maximum measured concentration)(6 weeks)
- AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(6 weeks)
- AUC 0-tz: The area under the plasma concentration-time curve over the time interval from 0 to the last timepoint at which concentrations of AbGn-168H can be measured(6 weeks)
- %AUC tz-infinity: The percentage of the AUC0-infinity obtained by extrapolation from the last evaluable timepoint(6 weeks)
- delta z (terminal rate constant in plasma)(6 weeks)
- t 1/2 (terminal half-life of the analyte in plasma)(6 weeks)