A Phase I, Randomized, Double-blind, Parallel Group and Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Atrosimab in Response to Single Ascending Intravenous Infusion Doses.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Any adverse event, serious adverse event (SAE)
研究概览
简要总结
This is a double-blind, parallel group and placebo-controlled clinical study to assess safety tolerability, pharmacokinetics and pharmacodynamics of Atrosimab in healthy 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •healthy male subjects
- •body mass index 18-32 kg/m2
- •normal physical examination, clinical laboratory values and ECG
- •additional inclusion criteria apply
排除标准
- •febrile or infectious illness at least 7 days prior to the first administration
- •any active physical disease, acute or chronic
- •history of alcohol or drug abuse
- •history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological, endocrinological, immunological, psychiatric, or cardio-vascular disease, myopathies and bleeding tendency
- •additional exclusion criteria apply
结局指标
主要结局
Any adverse event, serious adverse event (SAE)
时间窗: 4 weeks
PK: Area under the plasma concentration curve from administration until the last quantifiable sampling point (AUC 0-t)
时间窗: 8 days
PK: Apparent terminal elimination rate constant (λz)
时间窗: 8 days
PK: Apparent volume of distribution (Vz)
时间窗: 8 days
PK: Maximum Plasma Concentration [Cmax]
时间窗: 8 days
PK: Clearance (CL)
时间窗: 8 days
pharmacokinetic (PK): Area under the analyte concentration-time curve from time 0 and extrapolated to infinite time (AUC 0-∞)
时间窗: 8 days
PK: Terminal half life (t1/2)
时间窗: 8 days
PK: Mean residence time (MRT)
时间窗: 8 days
次要结局
未报告次要终点