A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of the Safety and Tolerability of REGN475 in Healthy Subjects

Regeneron Pharmaceuticals1 个研究点分布在 1 个国家目标入组 56 人开始时间: 2009年2月1日最近更新: 2012年5月10日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Regeneron Pharmaceuticals
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.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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.