NCT00688012已完成1 期
A Placebo-controlled, Double-blind, Randomized, Single Dose, Dose Escalating Trial in Healthy Men to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPC3649
Santaris Pharma A/S2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2008年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
研究概览
简要总结
A placebo-controlled, double-blind, randomized, single dose, dose escalating trial in healthy men to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPC3649.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers
- •BMI: 19-28 kg/m2
- •No clinically significant disease/disorder
- •Screening laboratory tests without clinically significant abnormalities, must agree to use condoms during intercourse for one week after study drug infusion
- •Following receipt of verbal and written information about the study, the subject must provide signed informed consent before any study related activity is carried out.
排除标准
- •Heavy exercise within the past 7 days
- •Alcohol intake> 21 units weekly
- •Regular smoker
- •Received experimental drug within 30 days of study entry
- •Planned participation in any experimental study during the study period
- •HIV-Ab, HBsAg and/or HCV Ab positive
- •History of specific allergy
- •Current use of any drug or narcotics.
研究者
研究点 (2)
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