NCT04612062已完成1 期
A First-in-Human Study to Determine Safety, Tolerability and Systemic Exposure of Topically Applied CEE321 Cream in Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
Open label, non-randomized, uncontrolled, First-in-Human Phase 1 Study in Healthy Subjects and Subjects with Atopic Dermatitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label Study
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Healthy Subjects (Part A)
Experimental
CEE321 0.2% (3 mg/cm2) topical cream b.i.d.
干预措施: CEE321 (Drug)
Atopic Dermatitis (Part B)
Experimental
CEE321 0.2% (3 mg/cm2) topical cream b.i.d.
干预措施: CEE321 (Drug)
结局指标
主要结局
Number of subjects with adverse events
时间窗: adverse events recorded during study
次要结局
- Plasma trough concentration of CEE321(day 15)
研究者
研究点 (1)
Loading locations...
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