NCT06927960

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

Completed Phase 1 Last updated 19 December 2025

What this trial tests

Phase 1 trial testing AH-001 or placebo in Androgenetic Alopecia in 64 participants. Completed in 16 July 2025.

Timeline

24 March 2025

Primary endpoint
16 July 2025

16 July 2025

Quick facts

Lead sponsor	AnHorn Medicines Co. Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	64
Start date	24 March 2025
Primary completion	16 July 2025
Estimated completion	16 July 2025
Sites	1 location across United States

Drugs / interventions tested

• AH-001 or placebo — full drug profile →

Conditions studied

• Androgenetic Alopecia — all drugs for Androgenetic Alopecia →

Sponsor

AnHorn Medicines Co. Ltd. — full company profile →

Who can join

Adults 18 to 65, any sex, with Androgenetic Alopecia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Proteolysis-Targeting Chimera (PROTAC): Current Applications and Future Directions.
   Fan G, Chen S, Zhang Q, Yu N, et al · · 2025 · cited 6× · PMID 41049269 · DOI 10.1002/mco2.70401
2. Expanding the Scope of PROTACs: Opportunities and Challenges in Topical Delivery.
   Gioiello L, Di Martino RMC, Pirali T. · · 2025 · cited 2× · PMID 41255358 · DOI 10.1021/acs.jmedchem.5c01911
3. Mechanisms and Design Principles of Proteolysis-Targeting Chimeras and Their Emerging Applications.
   Knoll N, Neamati N, Üren A. · · 2026 · PMID 41988372 · DOI 10.1021/acsptsci.5c00730
4. PROTAC-based protein degradation: a window of opportunity for melanoma therapy.
   Gentile G, D'Aguanno S, Di Martile M, Petricca A, et al · · 2026 · PMID 41761284 · DOI 10.1186/s12929-026-01225-2