drugset / Trial / NCT06927960

Evaluation of the Safety, Tolerability and Pharmacokinetics of AH-001 Following Topical Single and Multiple Ascending Dose Administration

NCT06927960 ↗

Phase 1 Completed 64 enrolled AnHorn Medicines Co. Ltd.
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

EvaluationDrugModalityDoseRoute
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

Indications