drugset / Trial / NCT06927960
Evaluation of the Safety, Tolerability and Pharmacokinetics of AH-001 Following Topical Single and Multiple Ascending Dose Administration
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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).
Timeline
- Start
- 2025-03-24
- Primary completion
- 2025-07-16
- Completion
- 2025-07-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AH-001 | Unknown | 0.2 % | Topical |
| Subject | AH-001 | Unknown | 0.5 % | Topical |
| Subject | AH-001 | Unknown | 1 % | Topical |
| Subject | AH-001 | Unknown | 2 % | Topical |