NCT03218241已完成1 期
A Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445, a Factor Xa (fXa) Inhibitor Antidote
Portola Pharmaceuticals0 个研究点目标入组 32 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 主要终点
- Pharmacodynamics assessments
研究概览
简要总结
This is a single center, double-blind, randomized, placebo-controlled, ascending, single dose study of PRT064445 or its matching placebo, in healthy 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
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men or women between the ages of 18 and 50 years old, inclusive
- •BMI 19-32 and weighs at least 60kgs
排除标准
- •History or symptoms of bleeding problems or thrombotic conditions
- •Clinically significant medical history
- •Major surgery, severe trauma, or bone fracture within 3 months
研究组 & 干预措施
PRT064445 Dose 3
Experimental
Dose 3 versus Placebo
干预措施: PRT064445 (Biological)
PRT064445 Dose 3
Experimental
Dose 3 versus Placebo
干预措施: Placebo (Drug)
PRT064445 Dose 2
Experimental
Dose 2 versus Placebo
干预措施: PRT064445 (Biological)
PRT064445 Dose 2
Experimental
Dose 2 versus Placebo
干预措施: Placebo (Drug)
PRT0064445 Dose 1
Experimental
Dose 1 versus Placebo
干预措施: PRT064445 (Biological)
PRT0064445 Dose 1
Experimental
Dose 1 versus Placebo
干预措施: Placebo (Drug)
PRT064445 Dose 4
Experimental
Dose 4 versus Placebo
干预措施: PRT064445 (Biological)
PRT064445 Dose 4
Experimental
Dose 4 versus Placebo
干预措施: Placebo (Drug)
PRT064445 Dose 5
Experimental
Dose 5 versus Placebo
干预措施: PRT064445 (Biological)
PRT064445 Dose 5
Experimental
Dose 5 versus Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacodynamics assessments
时间窗: Up to 28 days
次要结局
- Pharmacokinetics: Plasma levels of PRT064445(Up to 7 days)
研究者
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