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
干预措施
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
- 1
- 主要终点
- The frequency of drug-related adverse events
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
研究组 & 干预措施
Placebo
Placebo Comparator
Multiple intravenous infusions of placebo
干预措施: Placebo (Biological)
CSL112
Experimental
Multiple ascending intravenous doses of CSL112
干预措施: CSL112 (Biological)
结局指标
主要结局
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
Clinically important elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
时间窗: up to 6 days 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 (1)
Loading locations...
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