临床试验/NCT00838461

NCT00838461已完成1 期

Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of HSD-016 Administered Orally to Healthy Subjects

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 32 人开始时间: 2009年3月最近更新: 2009年8月3日

适应症

干预措施

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: Safety will be evaluated from reported AEs, scheduled physical, vital sign measurements, 12 lead ECGs, and clinical laboratory test results.

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记录与标识符相似试验

研究概览

简要总结

This is intended to provide an initial safety assessment of HSD-016 and also to evaluate how the drug is absorbed and eliminated and its effect on the body 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: Treatment
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

未提供

排除标准

未提供

研究组 & 干预措施

1

Active Comparator

HSD-016

干预措施: HSD-016 (Drug)

2

Placebo Comparator

placebo

干预措施: placebo (Drug)

结局指标

主要结局

Safety will be evaluated from reported AEs, scheduled physical, vital sign measurements, 12 lead ECGs, and clinical laboratory test results.

时间窗: 3 months

次要结局

Levels of drug concentrations will be evaluated after receiving multiple doses of HSD-016(3 months)

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

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