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

NCT06927960 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-12-19

No results posted yet for this study

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).

Conditions

Interventions

DRUG

AH-001 or placebo

SAD: Subjects are planned to receive a single dose of AH-001 or placebo once MAD: Subjects are planned to receive a single daily dose of AH-001 or placebo for 7 consecutive days

Sponsors & Collaborators

  • AnHorn Medicines Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-24
Primary Completion
2025-07-16
Completion
2025-07-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06927960 on ClinicalTrials.gov