NCT02490787已完成1 期
A Multi-centre, Randomised, Placebo Controlled, Double Blinded, Multiple Dose Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects (Explorer™3)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of adverse events (AEs)
研究概览
简要总结
This trial is conducted globally. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of concizumab administered subcutaneously to haemophilia A subjects.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects diagnosed with haemophilia A without inhibitors present at screening and currently treated on-demand
- •Subjects with a baseline level of factor VIII below or equal to 2 % based on medical records
- •Age between 18 and 64 years both inclusive, at the time of signing informed consent
- •Body weight between 50 and 100 kg, both inclusive
排除标准
- •Known or suspected hypersensitivity to trial product or related products
- •Platelet count below 50x10^9/L at screening
- •Any clinical signs or known history of thromboembolic events, or subjects considered at high risk of thromboembolic events as judged by the investigator
- •Subjects at increased risk of cardiovascular disease as judged by the investigator
研究组 & 干预措施
Concizumab
Experimental
干预措施: Concizumab (Drug)
Concizumab
Experimental
干预措施: placebo (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Number of adverse events (AEs)
时间窗: From first trial drug administration (day 1) to 11 weeks after the first trial product administration
次要结局
- Trough level of concizumab(Prior to the last s.c. dose administration (day 42))
- Frequency of binding non-neutralizing anti-concizumab antibodies(From first trial drug administration (day 1) to 11 weeks after the first trial product administration)
研究者
研究点 (1)
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