NCT00965432已完成1 期
A Single-Dose, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study in Healthy, Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107
Seaside Therapeutics, Inc.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
The objectives of this study are to determine the safety and tolerability of single oral doses of STX107 and to determine basic pharmacokinetic (PK) parameters following single oral doses of STX107 when administered via an oral suspension
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Normal, healthy males 18-50 years old, inclusive.
- •Able to comprehend and willing to sign an Informed Consent Form (ICF).
排除标准
- •Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator).
研究组 & 干预措施
STX107
Active Comparator
干预措施: STX107 (Drug)
Placebo
Placebo Comparator
干预措施: STX107 (Drug)
结局指标
主要结局
Adverse events
时间窗: During the course of the study and for 14 days after completing the study
次要结局
未报告次要终点
研究者
研究点 (1)
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