NCT01281774已完成1 期
An Adaptive, Phase I, Randomised, Placebo-controlled, Sponsor-unblinded, Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous CSL112 in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- CSL Limited
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Clinically important elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CSL112 in healthy volunteers after multiple infusions.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females aged 18 years to less than 55 years
- •Body weight 50kg or greater
- •Body mass index (BMI) between 18 and 42.0 kg/m2
排除标准
- •Evidence of a clinically significant medical condition, disorder or disease
- •Evidence of hepatobiliary disease
- •Any clinically relevant abnormal laboratory test result
- •Evidence or history of alcohol or substance abuse
结局指标
主要结局
Clinically important elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
时间窗: up to 6 days after each infusion
The frequency of drug-related adverse events
时间窗: Up to 6 days after each infusion
The frequency of redness and swelling at the infusion site
时间窗: up to 24 hours after each infusion
次要结局
- Pharmacokinetic profile of apoA-I after multiple intravenous infusions(up to 7 days after each infusion)
研究者
研究点 (2)
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