NCT01002950已完成2 期
Multicenter, Randomized, Double-Masked, Placebo-Controlled, Dose Escalation, Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACU-4429 in Subjects With Dry Age-Related Macular Degeneration (Geographic Atrophy)
Kubota Vision Inc.10 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 10
- 主要终点
- Safety as measured by: AEs, clinical laboratory tests, vital signs, physical exams, visual tests, and questionaire
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the investigational drug ACU-4429 in subjects with geographic atrophy.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a clinical diagnosis of geographic atrophy, as defined in the protocol
排除标准
- •Currently receiving or has received a medication prohibited by the protocol
研究组 & 干预措施
ACU-4429 tablet
Experimental
干预措施: ACU-4429 (Drug)
Matching placebo tablet
Placebo Comparator
干预措施: Matching placebo (Drug)
结局指标
主要结局
Safety as measured by: AEs, clinical laboratory tests, vital signs, physical exams, visual tests, and questionaire
时间窗: Through treatment period (up to Day 90) until 1-2 weeks post last dose (Day 97-104)
次要结局
- Pharmacokinetics as measured by plasma ACU-4429 drug levels(Baseline; Treatment Days 2, 7, 14, 30, 60 and 90)
研究者
研究点 (10)
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