JPRN-jRCT2080224835招募中1 期
A PHASE I/II STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF NXT007 IN HEALTHY VOLUNTEERS AND PATIENTS WITH HEMOPHILIA A (NXTAGE)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 106
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 12age old 至 <= 59age old（—）
- 性别
- Male
入选标准
- •[Healthy volunteer]
- •- Japanese
- •- Age 20 - 44 years, inclusive
- •- Severe congenital hemophilia A
- •- Age 12 - 59 years, inclusive
- •- Documented bleeding episodes (bleeding period, bleeding site) and the therapeutic history with blood coagulation factor products for 24 weeks prior to enrollment
排除标准
- •[Healthy volunteer]
- •- Previous or concomitant thromboembolic (TE) disease such as deep vein thrombosis (DVT), or signs of TE disease or thrombotic microangiopathy (TMA)
- •- Bleeding disorder other than congenital hemophilia A
- •- Previous or concomitant thromboembolic (TE) disease such as deep vein thrombosis (DVT), or signs of TE disease or thrombotic microangiopathy (TMA)
- •- Planned immune tolerance induction (ITI) therapy during the study period
研究者
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