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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called AH-001, a potential drug for male pattern baldness, focusing on its safety at different doses. Participants will include healthy volunteers and men experiencing hair loss due to androgenetic alopecia, a common form of hair loss. The trial will assess how well participants tolerate the treatment and how the body processes it. Men with ongoing hair loss and no scalp conditions or treatments affecting hair growth might be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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 there any evidence suggesting that AH-001 is likely to be safe for humans?

Research has shown that AH-001 is safe and well-tolerated. In earlier studies, AH-001 demonstrated a strong safety record, with no serious side effects. Tested in strengths ranging from 0.2% to 2%, the drug showed no negative effects. This trial is important as it examines how the body processes single and multiple doses of AH-001. The results so far are promising for potential participants. Safety remains a top priority, and AH-001 appears to meet the standard. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for male pattern baldness?

Unlike the standard treatments for male pattern baldness, such as finasteride and minoxidil, AH-001 offers a unique approach by utilizing varying concentrations of its active ingredient, which may target hair growth more precisely. Researchers are excited about the potential of AH-001 because it could provide a more tailored treatment with its different concentrations — 0.2%, 0.5%, 1%, and 2% — allowing for customization based on individual patient needs. This approach might lead to better outcomes with fewer side effects, making it a promising alternative for those seeking new solutions for hair loss.

What evidence suggests that AH-001 might be an effective treatment for male pattern baldness?

Research has shown that AH-001 improves hair growth and appearance in men with male pattern baldness, also known as androgenetic alopecia (AGA). Studies have found that participants using AH-001 experienced noticeable hair regrowth by the study's end. This trial will test different concentrations of AH-001—0.2%, 0.5%, 1%, and 2%—to evaluate its effectiveness. AH-001 could be a promising option for those dealing with hair loss, as it addresses the root causes of hair thinning and loss, often linked to genetics. While these early results are promising, further research is needed to fully understand AH-001's effectiveness. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. withpower.com withpower.com/trial/phase-1-alopecia-2-2025-c258a

AH-001 for Male Pattern Baldness The treatment resulted in significant improvements in hair growth, hair restoration, and overall hair appearance by the end of the study, indicating its ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10173235/

Androgenetic Alopecia: Therapy Update - PMC A randomized control trial (RCT) showed better results with 1 mg finasteride than 5% minoxidil foam in 65 male patients with mild to severe AGA ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04435847

Safety and Efficacy of HST 001 in Male Pattern Hair Loss Phase 1b, Double-Blind, Placebo-controlled Study of Safety and Efficacy of HST 001 in Male Subjects With Male Pattern Hair Loss Conditions

4. malacards.org malacards.org/card/alopecia_androgenetic_1

Alopecia, Androgenetic, 1 (AGA1) Male pattern hair loss is genetically determined, with only 30% of men developing extensive hair loss. Female pattern hair loss is generally less pronounced ...

5. nature.com nature.com/articles/s41598-022-05544-w

Weekly treatment with SAMiRNA targeting the androgen ... In low-dose (0.5 mg/ml) clinical study I, the total hair count of the AR68 treatment group increased by 1.870% (from 133.14 to 135.41 hairs/cm2) ...

6. anhornmed.com anhornmed.com/news/ai-design-ah001-protein-degrader-phase1-complete/

AI-Designed Drug AH-001 Complete U.S. Phase I Trial ... Preclinical and Phase I data demonstrated a strong safety profile and excellent local tolerability, setting the stage for dose optimization and ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06927960

Study Details | NCT06927960 | Evaluation of the Safety, ... To evaluate the safety, tolerability, and pharmacokinetics profiles of multiple ascending doses (MAD) of AH-001 in male subjects with androgenetic alopecia (AGA) ...

8. trial.medpath.com trial.medpath.com/news/40e14569f4b8e223/anhorn-medicines-ai-designed-hair-loss-drug-ah-001-completes-phase-i-trial-with-excellent-safety-profile

AnHorn Medicines' AI-Designed Hair Loss Drug AH-001 ... The trial confirmed AH-001 was safe and well-tolerated across all dose levels with no drug-related adverse events, demonstrating the clinical ...

9. finance.yahoo.com finance.yahoo.com/news/ai-designed-drug-ah-001-163800273.html

AI-Designed Drug AH-001 Complete U.S. Phase I Trial ... Preclinical and Phase I data demonstrated a strong safety profile and excellent local tolerability, setting the stage for dose optimization and ...