Androgenetic AlopeciaPhase 1NCT06927960
Evaluation of the Safety, Tolerability and Pharmacokinetics of AH-001 Following Topical Single and Multiple Ascending Dose Administration
A Phase 1 study of Androgenetic Alopecia, run by AnHorn Medicines Co. Ltd. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2025to 16 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Treatment sites (scalp skin) must be free of scars, tattoos, or dermatological defects that might impair measurements.
Who cannot join
- 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.
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- 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.
- Smoking more than 5 cigarettes per day within 3 months before the study and inability to stop smoking within 7 days before the first dosing until 2 days after the last dosing.
- Use of prescription or over-the-counter medications and herbal supplements (including St John's Wort, herbal teas, and garlic extracts) within 30 days before the first dosing until 2 days after the last dosing (except for paracetamol/acetaminophen, ibuprofen, and hormonal contraceptives).
- For females of childbearing potential: Unwillingness to use a highly effective contraceptive method (method of birth control which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, non-hormonal or hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner) during sexual intercourse with a partner of childbearing potential throughout the study and for 1 month after its completion. Only males capable of reproduction are required to use a reliable form of contraception throughout the study and for 1 month after study completion (vasectomized males of at least 6 months are exempt).
- Employment or affiliation with the investigator, study site, sponsor, or contract research organization.
- Other conditions affecting compliance, as determined by the investigator, or inability to participate in the study for personal reasons.
- Inability to communicate or cooperate with healthcare professionals due to neurological, psychiatric, or language disorders.
- For Cohort 5~8 (MAD):
- Subjects with dermatological disorders of the scalp in the target region that may interfere with the application of the investigational drug-such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy-or with skin pathology or conditions that could affect the evaluation of the investigational drug or require interfering therapy, including topical, systemic, or surgical treatments.
- Genetic disorders affecting hair growth or patterns or requiring certain treatments.
- History of hair weaves, non-breathable wigs, hair transplant or hair bonding that will interfere with applying the investigational drug or observing safety and tolerability.
- History of active hair loss due to conditions other than AGA, such as diffuse telogen effluvium, alopecia areata, scarring alopecia, or trichotillomania.
- Severe dietary or weight changes within the past six months, or a history of eating disorders that has contributed to hair loss in the opinion of the Investigator.
- Subjects that used topical scalp treatments for the management of hair loss (including minoxidil, anti-androgens) or a history of radiation of the scalp within the last 4 weeks prior to dosing.
- Unstable disorders in various systems that could affect subject safety throughout the study, as determined by the investigator.
- Subjects will not be administered with study drug if they meet any of the following rules at admission:
- Any abnormal laboratory values at admission: Hb <12.0g/dL for women and < 13.0 g/dL for men, WBC < 3,000 cells/mm3, absolute neutrophil count < 1,500 cells/mm3, platelet count < 100,000 cells/mm3, serum creatinine ≥ 2 mg/dL, ALT or AST levels ≥ 2 x ULN, total bilirubin ≥ 1.5 x ULN, Prothrombin Time (PT) ≥ 1.5 x ULN
- Any abnormal laboratory values that are considered clinically significant by the Investigator at admission
- Any clinically significant abnormality on 12-lead ECG or a QT interval corrected with the Fridericia formula (QTcF) greater than 450 msec for females and 430 msec for males at admission
- Positive urine drug screen or breath test at admission
- If female, positive serum pregnancy test at admission
- Acute illness within 2 weeks before dosing, unless approved by the Sponsor's Medical Monitor
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Los Angeles, Inc.
Los Angeles, California, 90630
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study in Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of AH-001 Following Topical Single and Multiple Ascending Dose Administration
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
- Being tested
- AH-001 or placebo
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AH-001 or placeboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 2% AH-001 | Experimental | Not described Receives: Drug: AH-001 or placebo |
| 1% AH-001 | Experimental | Not described Receives: Drug: AH-001 or placebo |
| 0.5% AH-001 | Experimental | Not described Receives: Drug: AH-001 or placebo |
| 0.2% AH-001 | Experimental | Not described Receives: Drug: AH-001 or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of subjects with treatment-emergent adverse events
Measured: From the first dose until 2 days after the last dose
Changes from baseline in local skin reaction
Measured: From the first dose until 2 days after the last dose
Pharmacokinetic characterization of Cmax for AH-001
Measured: From the first dose until 2 days after the last dose
Pharmacokinetic characterization of Tmax for AH-001
Measured: From the first dose until 2 days after the last dose
Pharmacokinetic characterization of AUC for AH-001
Measured: From the first dose until 2 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start24 Mar 2025
- Primary completion16 Jul 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- AnHorn Medicines Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927960
- Sponsor's protocol ID
- AH-001-01
- Status last verified
- Dec 2025
- First submitted
- 7 Apr 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study in Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of AH-001 Following Topical Single and Multiple Ascending Dose Administration
- ClinicalTrials.gov ID
- NCT06927960
- Acronym / sponsor ID
- AH-001-01
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AnHorn Medicines Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (36 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AH-001 or placeboSAD: 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 | Drug | 0.2% AH-001, 0.5% AH-001, 1% AH-001, 2% AH-001 |
Primary outcome
Number and percentage of subjects with treatment-emergent adverse events
Time frame: From the first dose until 2 days after the last dose
Changes from baseline in local skin reaction
Time frame: From the first dose until 2 days after the last dose
Pharmacokinetic characterization of Cmax for AH-001
Time frame: From the first dose until 2 days after the last dose
Pharmacokinetic characterization of Tmax for AH-001
Time frame: From the first dose until 2 days after the last dose
Pharmacokinetic characterization of AUC for AH-001
Time frame: From the first dose until 2 days after the last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Androgenetic Alopecia, run by AnHorn Medicines Co. Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of subjects with treatment-emergent adverse events (time frame: From the first dose until 2 days after the last dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.