Evaluation of the Safety, Tolerability and Pharmacokinetics of AH-001 Following Topical Single an… (NCT06927960) | Clinical Trial Compass
CompletedPhase 1
Evaluation of the Safety, Tolerability and Pharmacokinetics of AH-001 Following Topical Single and Multiple Ascending Dose Administration
United States64 participantsStarted 2025-03-24
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
What they're measuring
1
Number and percentage of subjects with treatment-emergent adverse events
Timeframe: From the first dose until 2 days after the last dose
2
Changes from baseline in local skin reaction
Timeframe: From the first dose until 2 days after the last dose
3
Pharmacokinetic characterization of Cmax for AH-001
Timeframe: From the first dose until 2 days after the last dose
4
Pharmacokinetic characterization of Tmax for AH-001
Timeframe: From the first dose until 2 days after the last dose
5
Pharmacokinetic characterization of AUC for AH-001
Timeframe: From the first dose until 2 days after the last dose
✕. 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.