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

NCT06927960 | Completed Phase 1 FDA Drug

• 1 other identifier: AH-001-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (5)

• Number and percentage of subjects with treatment-emergent adverse events

  From the first dose until 2 days after the last dose

• Changes from baseline in local skin reaction

  From the first dose until 2 days after the last dose

• Pharmacokinetic characterization of Cmax for AH-001

  From the first dose until 2 days after the last dose

• Pharmacokinetic characterization of Tmax for AH-001

  From the first dose until 2 days after the last dose

• Pharmacokinetic characterization of AUC for AH-001

  From the first dose until 2 days after the last dose

Study Arms (4)

2% AH-001

EXPERIMENTAL

Drug: AH-001 or placebo

1% AH-001

EXPERIMENTAL

Drug: AH-001 or placebo

0.5% AH-001

EXPERIMENTAL

Drug: AH-001 or placebo

0.2% AH-001

EXPERIMENTAL

Drug: AH-001 or placebo

Interventions

AH-001 or placebo DRUG

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

0.2% AH-001; 0.5% AH-001; 1% AH-001; 2% AH-001

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet the following criteria to be eligible for participation in the study:
• For all (Cohort 1\~8):
• Age range: 18 to 65 years.
• Body weight: ≥ 50 kg for males, ≥ 45 kg for females; Body Mass Index (BMI) 19 to 30 kg/m2 (inclusive).
• Subjects understand and agree to comply with planned study procedures, can communicate well with the investigator, understand the requirements of the study, and have provided written informed consent.
• Following the assessment, the principal investigator considered the individual healthy, including a detailed medical history, complete physical examination, clinical laboratory tests, 12-lead ECG, and vital signs evaluation.
• No history of excessive sensitivity or allergic reactions to topical formulations.
• For Cohort 1\~4 (SAD):
• Healthy subjects, including males or non-pregnant, non-breastfeeding females.
• The skin of the upper arm must be healthy without damage or wound.
• Treatment sites (upper arm skin) must be free of scars, tattoos, or dermatological defects that might impair measurements.
• For Cohort 5\~8 (MAD):
• Male subjects with a clinical diagnosis of mild to severe AGA; rating III to VII (contains III Vertex, IIIa, IVa, and Va) on the modified Norwood Hamilton Scale, with a history of ongoing hair loss.
• Willingness to maintain the same hairstyle, hair length, hair color, and hair care regimen throughout the study.
• The skin of the scalp must be healthy without damage or wounds.

You may not qualify if:

• Subjects are excluded from this study if any 1 or more of the following criteria is met:
• For all (Cohort 1\~8):
• History of allergy to the investigational drug or its components.
• Individuals who used systemic treatment (including finasteride, oral minoxidil, dutasteride or similar products) that is known to or reasonably believed in the opinion of the Investigator to affect hair growth within the last 3 months prior to dosing.
• Presence of any visible skin disease, damage, or condition at the application site that, in the investigator's opinion, may jeopardize subject safety or interfere with the assessment of the test site reaction.
• Clinical history of clinically significant disorders in various systems (including gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, and lipid metabolism) that may limit the ability to assess the associated adverse events based on Investigational judgement or known or suspected malignancy.
• Positive blood screen for human immunodeficiency virus (HIV) or syphilis. Positive blood screen for active infection of hepatitis B or hepatitis C
• Hospital admission or planned or anticipated major surgical procedure that would interfere with the ability to comply with protocol requirement within 30 days prior to screening.
• Participation in another investigational drug trial within 3 months before the first dosing.
• History of prescription drug abuse or illicit drug use within 6 months prior to screening or a positive screen for drugs of abuse.
• Excessive alcohol consumption (\>14 units per week, 1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits containing 40% alcohol or 150 mL of wine) within 3 months prior to signing the informed consent form, or a positive breath or urine alcohol test results the day before dosing, or inability to abstain from alcohol during the study.
• Chronic consumption of excessive tea, coffee, or caffeine-containing beverages (\>8 cups per day, 1 cup = 240 mL) within 6 months before dosing.
• Consumption of caffeine, alcohol, xanthine, or grapefruit-containing beverages within 48 hours the first dose and stay-on-site period.
• Difficulty with blood collection, intolerance to venipuncture, or a history of needle phobia or hemophobia.
• Blood donation from 7 days before the first dosing until 2 days after the last dosing. Loss of ≥450 mL of blood within 3 months before the first dosing.

Sponsors & Collaborators

• AnHorn Medicines Co. Ltd.: lead

Study Sites (1)

Altasciences Clinical Los Angeles, Inc.

Los Angeles, California, 90630, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

AH 001

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: March 24, 2025
• Primary Completion: July 16, 2025
• Study Completion: July 16, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

US (1)