NCT02189733已完成1 期
A Phase I, Single Center, Open-Label, Randomized, Single Dose Cross-Over Study in Healthy Male Subjects to Investigate the Bioequivalence and Tolerability of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.
Ablynx, a Sanofi company2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2014年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Pharmacokinetics: concentration of caplacizumab in plasma
研究概览
简要总结
The primary objective of the study is to evaluate the pharmacokinetic characteristics and demonstrate bioequivalence of a reconstituted new lyophilized formulation of caplacizumab for subcutaneous (s.c.) injection as compared to an equal nominal s.c. dose of the reference liquid formulation of caplacizumab.
The secondary objective of the study is to compare the safety and tolerability, and the pharmacodynamic parameters of the new formulation with those of the reference formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male Caucasians aged 18 to 55 years, inclusive.
- •Body weight 55 - 100 kg and body mass index (BMI) between 18.5 and 30.0, extremes included.
- •Coagulation and bleeding diathesis variables (as defined in the protocol) within the normal range at screening and on Day -
- •Others as defined in the protocol.
排除标准
- •History or presence of diseases in the kidneys and/or heart, lungs, liver, skin, endocrine organs or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- •History of and/or any sign or symptom indicating current abnormal hemostasis or blood dyscrasia.
- •Others as defined in the protocol
结局指标
主要结局
Pharmacokinetics: concentration of caplacizumab in plasma
时间窗: Day 1 (pre-dose) until Day 7
次要结局
- Pharmacodynamics as measured by Ristocetin cofactor activity in plasma(During screening until day 29 +/-1)
- Pharmacodynamics as measured by Factor VIII clotting activity in plasma(During screening until day 29 +/- 1)
- Safety and Tolerability: safety markers(From signing of informed consent form until day 43 +/- 2)
- Pharmacodynamics as measured by von Willebrand factor antigen in plasma(During screening until Day 29 +/- 1)
研究者
研究点 (2)
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