NCT00856310已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of the Safety and Tolerability of REGN475 in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Incidence of treatment emergent adverse events in subjects treated with REGN475 or placebo.
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled single-dose study of the safety and tolerability of intravenously administered REGN475 in healthy volunteers. The primary objective of the study is to assess the safety and tolerability of REGN475. The secondary objectives are to characterize the pharmacokinetic and immunogenicity profiles of REGN475.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female volunteers, in general good health and 21 to 65 years of age.
- •Female volunteers must be post-menopausal for at least 1 year or surgically sterile.
排除标准
- •Significant concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, GI, hepatic, metabolic or lymphatic disease that would adversely affect the subject's participation in this study or interpretation of safety/ PK data
- •Participation in any clinical research study evaluating another investigational drug or therapy within 3 weeks or at least 5 half-lives of the investigational drug, whichever is longer, prior to the Screening Visit.
结局指标
主要结局
Incidence of treatment emergent adverse events in subjects treated with REGN475 or placebo.
时间窗: 16 weeks
次要结局
- Serum concentrations of REGN475.(16 Weeks)
- The presence or absence of antibodies against REGN475.(16 Week follow up)
研究者
研究点 (1)
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