NCT00612417已完成1 期
A Randomised, Double-blind and Placebo-controlled Study Investigating the Pharmacodynamic Effects of Administration of Recombinant Human Factor VIII in Healthy Male Subjects Treated With the Monoclonal Anti-factor VIII Antibody, TB-402
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
- 12
- 试验地点
- 1
- 主要终点
- Changes in coagulation parameters after rFVIII administration
研究概览
简要总结
Single administration of recombinant FVIII/placebo in healthy male subjects who have been treated with a single dose of anti-factor VIII antibody, TB-402
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
recombinant FVIII
干预措施: Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402 (Drug)
2
Placebo Comparator
Placebo
干预措施: Administration of recombinant FVIII/placebo in healthy male subjects treated with TB-402 (Drug)
结局指标
主要结局
Changes in coagulation parameters after rFVIII administration
时间窗: To study end
次要结局
- PD of TB-402, safety of TB-402 alone and with rFVIII, PK of FVIII in rFVIII-treated subjects, changes in coagulation parameters after TB-402 administration(To study end)
研究者
研究点 (1)
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