A Phase 1, Open-Label Study to Assess the Pharmacokinetics, and Safety and Tolerability of a Single Intravenous Injection of rFVIIIFc-VWF-XTEN (BIVV001) in Adults With Type 2N and 3 Von Willebrand Disease (VWD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Pharmacokinetic Parameter: Maximum plasma concentration observed (Cmax)
研究概览
简要总结
Primary Objective:
-To characterize the pharmacokinetics (PK) of BIVV001 after a single intravenous (IV) administration, as assessed by factor VIII (FVIII) activity determined by the one-stage activated partial thromboplastin time (aPPT) clotting assay, as well as, BIVV001 capture chromogenic Coatest FVIII activity assay
Secondary Objective:
-To assess the safety and tolerability of a single IV dose of BIVV001 in adult patients with type 2N and 3 VWD
详细描述
Duration of each part of the study for one participant:
Total study duration: Up to 57 days.
- Screening: up to 28 days.
- Up to 29 days of safety observation following the IV BIVV001 dose administration (this period includes PK sampling up to the first 10 days following administration).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
efanesoctocog alfa (BIVV001)
A single IV dose of BIVV001 will be administered to each patient
干预措施: efanesoctocog alfa (BIVV001) (Drug)
结局指标
主要结局
Pharmacokinetic Parameter: Maximum plasma concentration observed (Cmax)
时间窗: Day 1 to Day 10
Pharmacokinetic Parameter: Terminal half-life (t½z)
时间窗: Day 1 to Day 10
Pharmacokinetic Parameter: Total Clearance (CL)
时间窗: Day 1 to Day 10
Pharmacokinetic Parameter: Volume of distribution at steady state (Vss)
时间窗: Day 1 to Day 10
Pharmacokinetic Parameter: Area under the activity time curve extrapolated to infinity (AUC∞)
时间窗: Day 1 to Day 10
Pharmacokinetic Parameter: Mean residence time (MRT)
时间窗: Day 1 to Day 10
Pharmacokinetic Parameter: Incremental recovery (IR)
时间窗: Day 1 to Day 10
次要结局
- Number of participants with adverse events(Up to Day 29)