NCT01129661已完成1 期
An Adaptive, Phase I, Single-Centre, Randomised, Double-blind, Placebo-controlled Single 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
- 57
- 试验地点
- 1
- 主要终点
- Safety and tolerability as measured by the frequency of drug-related clinical adverse events.
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of escalating doses of CSL112 after single intravenous infusions in healthy volunteers and to measure the pharmacokinetics of CSL112 after single intravenous infusions 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 54 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 weigh 45 kg or greater
排除标准
- •Evidence of a clinically significant medical condition, disorder or disease
- •Evidence of clinically relevant abnormal laboratory test result
- •Evidence of history of alcohol or substance abuse
研究组 & 干预措施
normal saline (0.9%)
Placebo Comparator
干预措施: normal saline (0.9%) (Biological)
CSL112
Experimental
干预措施: CSL112 (reconstituted HDL) (Biological)
结局指标
主要结局
Safety and tolerability as measured by the frequency of drug-related clinical adverse events.
时间窗: Up to 14 days after infusion of CSL112
Safety and tolerability as measured by liver function tests.
时间窗: Up to 14 days after infusion of CSL112
次要结局
- Pharmacokinetics of lipoprotein.(Up to 10 days after infusion of CSL112)
研究者
研究点 (1)
Loading locations...
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