NCT00703183已完成1 期
A Single Center, Randomized, Double-Masked, Dose-Escalating, Placebo-Controlled Study of the Safety and Tolerability ACU-4429 in Healthy Volunteers
Kubota Vision Inc.1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2008年5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
- 46
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of a new investigational drug (ACU-4429) in healthy human volunteers.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is male or female with age ≥ 55 and ≤ 80 years at the time of consent
- •Is healthy as determined by medical history and physical examination
排除标准
- •Is receiving or has recently received treatment with a medication disallowed per the protocol
研究组 & 干预措施
2
Placebo Comparator
matching placebo
干预措施: matching placebo (Drug)
1
Experimental
ACU-4429
干预措施: ACU-4429 (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 7 days
次要结局
- Pharmacokinetics(2 days)
研究者
研究点 (1)
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