NCT00432770已完成1 期
A Phase 1, Single-Site, Double-Blind,Randomized, Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus or Intravenous Bolus Followed by Continuous Infusion Administration of ARC1779 Compared to Placebo in Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to establish the overall safety and tolerability of ARC1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von Willebrand Factor activity.
详细描述
The purpose of this study is to establish the overall safety and tolerability of ARC1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von Willebrand Factor activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- 是
入选标准
- •≥ 18 to ≤ 65 years of age
- •Weight ≤ 110 kg
- •Negative qualitative urine drug/alcohol test
- •Female volunteers must be of non-childbearing potential
- •Male volunteers must agree to use a medically acceptable contraceptive
- •Volunteers must be capable of understanding and complying with the protocol and must have signed the informed consent document
排除标准
- •Any clinically significant medical disorder (e.g. diabetes, hypertension, etc.)
- •Tendency to bleed easily
- •History of recent trauma or surgery
- •History of gout or renal stones
- •Clinically significant abnormal lab parameters for the following:
- •PT INR > 1.4
- •aPTT > reference laboratory values
- •Serum creatinine > 1.3 mg/dL
- •Platelet count of ≤ 100,000/mm3
- •ALT/AST > 2 times ULN
- •WBC ≤ 3000 x 109/L
- •Hemoglobin < 11 g/dL
- •Total bilirubin > 1.2 mg/dL
- •CBT > 15 min
研究者
研究点 (2)
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