NCT00977886已完成1 期
A Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Oral ELB353 in Healthy Male Volunteers - A Double-Blind, Randomized, Placebo-controlled, Sequential Group Study
Biotie Therapies Corp.1 个研究点 分布在 1 个国家目标入组 48 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
- 48
- 试验地点
- 1
- 主要终点
- Adverse event frequency and intensity
研究概览
简要总结
The purpose of this trial is to study the safety and tolerability of repeated oral doses of ELB353, to evaluate the plasma levels of ELB353 and to study their effect on substances mediating inflammation.
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
- Triple (Participant, 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
- 未提供
排除标准
- •Concomitant medication
- •Concomitant disease
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
ELB353
Experimental
干预措施: ELB353 (Drug)
结局指标
主要结局
Adverse event frequency and intensity
时间窗: 1 month
次要结局
- Plasma levels of ELB353(1 month)
- Inflammatory transmitter response ex vivo(2 weeks)
研究者
研究点 (1)
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