AH-001 for Male Pattern Baldness

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AnHorn Medicines Co. Ltd.

Must not be taking: Finasteride, Minoxidil, Dutasteride, others

Disqualifiers: HIV, Hepatitis B/C, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

64 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

Yes, you will need to stop taking certain medications. Specifically, you cannot have used systemic treatments like finasteride, oral minoxidil, or similar products affecting hair growth within the last 3 months, and you must avoid prescription or over-the-counter medications and herbal supplements (except for paracetamol/acetaminophen, ibuprofen, and hormonal contraceptives) within 30 days before the first dosing until 2 days after the last dosing.

Is AH-001 safe for treating male pattern baldness?

Finasteride, a treatment for male pattern baldness, has a well-established safety profile and was originally developed for another condition. Dutasteride, another similar treatment, showed long-term safety and tolerability in a study, with mild side effects like nasopharyngitis (common cold), erectile dysfunction, and decreased libido. ^{1 2 3 4 5}

How is the drug AH-001 different from other treatments for male pattern baldness?

The treatment AH-001 is unique because it targets multiple molecular pathways involved in hair growth and hair follicle stem cell biology, unlike existing treatments like minoxidil and finasteride, which have more specific mechanisms of action. ^{3 5 6 7 8}

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for healthy volunteers and men with male pattern baldness (androgenetic alopecia). Participants must meet specific health criteria, which are not detailed here.

Inclusion Criteria

Unstable disorders in various systems that could affect subject safety throughout the study, as determined by the investigator.

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.

I am considered healthy by the principal investigator after a thorough health assessment.

Exclusion Criteria

Subjects are excluded from this study if any 1 or more of the following criteria is met:

History of allergy to the investigational drug or its components.

Participation in another investigational drug trial within 3 months before the first dosing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD) Treatment

Evaluation of safety, tolerability, and pharmacokinetics of a single ascending dose of AH-001 in healthy volunteers

4 weeks

Multiple Ascending Dose (MAD) Treatment

Evaluation of safety, tolerability, and pharmacokinetics of multiple ascending doses of AH-001 in male subjects with androgenetic alopecia

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AH-001

Trial Overview The trial tests the safety of a new drug called AH-001 at various strengths (0.2%, 0.5%, 1%, and 2%) to see how it's tolerated and how it moves through the body when given once or multiple times.

Participant Groups

Group I: 2% AH-001 Experimental Treatment 1 Intervention

Group II: 1% AH-001 Experimental Treatment 1 Intervention

Group III: 0.5% AH-001 Experimental Treatment 1 Intervention

Group IV: 0.2% AH-001 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

AnHorn Medicines Co. Ltd.

Lead Sponsor

Findings from Research

Dutasteride 0.5 mg, taken daily for 52 weeks, demonstrated long-term safety and tolerability in 120 Japanese male patients with androgenetic alopecia, with mild adverse events like nasopharyngitis and erectile dysfunction reported in 17% of participants, none leading to withdrawal from the study.

The treatment resulted in significant improvements in hair growth, hair restoration, and overall hair appearance by the end of the study, indicating its efficacy as a potential treatment for male pattern hair loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of dutasteride in the treatment of male patients with androgenetic alopecia. Tsunemi, Y., Irisawa, R., Yoshiie, H., et al.[2022]

A systematic review and meta-analysis of randomized controlled trials found that minoxidil, finasteride, and low-level laser light therapy are effective treatments for promoting hair growth in men with androgenetic alopecia, all showing significant improvement over placebo.

Minoxidil was also found to be effective for women with androgenetic alopecia, indicating its broader applicability as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of treatments for androgenetic alopecia: A systematic review and meta-analysis. Adil, A., Godwin, M.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of finasteride in the treatment of men with androgenetic alopecia (male pattern hair loss). [2016]

2. England pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of dutasteride in the treatment of male patients with androgenetic alopecia. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of ALRV5XR in men with androgenetic alopecia: A randomised, double-blinded, placebo-controlled clinical trial. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

The efficacy and safety of dutasteride compared with finasteride in treating men with androgenetic alopecia: a systematic review and meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of treatments for androgenetic alopecia: A systematic review and meta-analysis. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Androgenetic alopecia: a review. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Male pattern baldness. [2013]

8. Germany pubmed.ncbi.nlm.nih.gov

[Androgenetic alopecia in the male. Recent developments]. [2006]