NCT05262179Unknown1 期
A Phase 1 Clinical Trial to Explore Systemic Exposure of CTO0101 Eye Drops, Safety and Local Tolerability in Healthy Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Cmax,ss
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristic of CTO0101
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers
- •Written informed consent to participate in the trial
排除标准
- •Those who have a history of ophthalmic diseases and surgery within 5 years
- •Smokers with an average daily smoking amount exceeding 10 cigarettes
研究组 & 干预措施
CTO0101
Experimental
干预措施: CTO0101 (Drug)
Placebo (Vehicle)
Placebo Comparator
干预措施: Placebo (vehicle) (Other)
结局指标
主要结局
Cmax,ss
时间窗: Day8 of stage 2
t1/2,ss
时间窗: Day8 of stage 2
AUCτ,ss
时间窗: Day8 of stage 2
Tmax,ss
时间窗: Day8 of stage 2
RAAUCτ
时间窗: Day8 of stage 2
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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