A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study in Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of AH-001 Following Topical Single and Multiple Ascending Dose Administration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Number and percentage of subjects with treatment-emergent adverse events
研究概览
简要总结
The goal of this clinical trial is to assess the safety of the AH-001 drug substance at concentrations of 0.2%, 0.5%, 1%, and 2% in healthy volunteers and male subjects with androgenetic alopecia (AGA).
Primary objective:
- To evaluate the safety, tolerability, and pharmacokinetics profiles of a single ascending dose (SAD) of AH-001 in healthy volunteers.
- To evaluate the safety, tolerability, and pharmacokinetics profiles of multiple ascending doses (MAD) of AH-001 in male subjects with androgenetic alopecia (AGA).
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
- 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
2% AH-001
干预措施: AH-001 or placebo (Drug)
1% AH-001
干预措施: AH-001 or placebo (Drug)
0.5% AH-001
干预措施: AH-001 or placebo (Drug)
0.2% AH-001
干预措施: AH-001 or placebo (Drug)
结局指标
主要结局
Number and percentage of subjects with treatment-emergent adverse events
时间窗: From the first dose until 2 days after the last dose
Changes from baseline in local skin reaction
时间窗: From the first dose until 2 days after the last dose
Pharmacokinetic characterization of Cmax for AH-001
时间窗: From the first dose until 2 days after the last dose
Pharmacokinetic characterization of Tmax for AH-001
时间窗: From the first dose until 2 days after the last dose
Pharmacokinetic characterization of AUC for AH-001
时间窗: From the first dose until 2 days after the last dose
次要结局
未报告次要终点