Androgenetic AlopeciaPhase 1/2NCT07490327
Assessment of Dutasteride Topical Solution in Male Androgenetic Alopecia
A Phase 1/2 study testing AD-303A and AD-3031 in people with Androgenetic Alopecia, run by Moogene Medi Co., Ltd at 1 site in South Korea.
Trial summary
This is a randomized, open-label phase 1/2a study designed to evaluate the pharmacokinetics, pharmacodynamics, and safety of AD-303A (topical formulation) and AD-3031 in male patients with androgenetic alopecia. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- AD-303A and AD-3031
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2026to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male participants aged 19 to 55 years.
- Clinical diagnosis of androgenetic alopecia.
- Healthy as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests.
- Willing and able to comply with all study procedures and visit schedules.
Who cannot join
- History or presence of dermatologic conditions affecting the scalp other than androgenetic alopecia.
- Prior hair transplantation or scalp surgery that may affect evaluation of hair growth.
- Use of medications known to affect hair growth (e.g., finasteride, dutasteride, minoxidil) within 6 months prior to screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 03080
Seung Hwan Lee, Ph.D., 82-2-2072-2343, leejh413@snu.ac.kr
About this study
Official title: A Randomized, Open-label, Single and Multiple-dose, Parallel-design Phase 1/2a Clinical Trial to Evaluate the Pharmacokinetics/Pharmacodynamics and Safety of AD-303A and Oral Administration of AD-3031 in Male Androgenetic Alopecia Patients
This is a randomized, open-label phase 1/2a study designed to evaluate the pharmacokinetics, pharmacodynamics, and safety of AD-303A (topical formulation) and AD-3031 in male patients with androgenetic alopecia. The study aims to compare pharmacological characteristics and safety profiles to support dose selection for further clinical development.
- Conditions
- Androgenetic Alopecia
- Being tested
- AD-303A, AD-3031
- Keywords
- AD-303A / AD-3031, Androgenetic Alopecia, Dutasteride, Topical, 5-Alpha Reductase Inhibitor, Pharmacokinetics, Safety
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-303ADrug
Topical AD-303A applied to the scalp according to the study protocol.
AD-3031Drug
Oral AD-3031 administered according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| AD-303A Topical | Experimental | Participants receive topical AD-303A applied to the scalp according to the study protocol. Receives: Drug: AD-303A |
| Oral AD-3031 | Active comparator | Participants receive oral AD-3031 administered according to the study protocol. Receives: Drug: AD-3031 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of dutasteride
The maximum observed plasma concentration (Cmax) of dutasteride following administration of the study drug.
Measured: Up to Day14
Secondary outcomes (1)
Change from baseline in scalp dihydrotestosterone (DHT) concentration Description
Change from baseline in scalp tissue dihydrotestosterone (DHT) concentration measured following repeated administration of topical dutasteride.
Measured: Baseline to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm1 : Topical AD-303A applied to the scalp according to the study dosing schedule. Arm 2: Oral AD-3031 administered according to the study dosing schedule.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moogene Medi Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Responsible party
- Sponsor
- Investigators
- Seung Hwan Lee, Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490327
- Sponsor's protocol ID
- AD-303PK
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Phase 1/2a
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single and Multiple-dose, Parallel-design Phase 1/2a Clinical Trial to Evaluate the Pharmacokinetics/Pharmacodynamics and Safety of AD-303A and Oral Administration of AD-3031 in Male Androgenetic Alopecia Patients
- ClinicalTrials.gov ID
- NCT07490327
- Acronym / sponsor ID
- AD-303PK
- Conditions
- Androgenetic Alopecia
- Keywords
- AD-303A / AD-3031, Androgenetic Alopecia, Dutasteride, Topical, 5-Alpha Reductase Inhibitor, Pharmacokinetics, Safety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Moogene Medi Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Study start
- Apr 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Mar 2026 (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.
This is a randomized, open-label phase 1/2a study designed to evaluate the pharmacokinetics, pharmacodynamics, and safety of AD-303A (topical formulation) and AD-3031 in male patients with androgenetic alopecia. The study aims to compare pharmacological characteristics and safety profiles to support dose selection for further clinical development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Arm1 : Topical AD-303A applied to the scalp according to the study dosing schedule. Arm 2: Oral AD-3031 administered according to the study dosing schedule.
| Arm | Type | Receives |
|---|---|---|
| AD-303A Topical | Experimental | Drug: AD-303AParticipants receive topical AD-303A applied to the scalp according to the study protocol. |
| Oral AD-3031 | Active comparator | Drug: AD-3031Participants receive oral AD-3031 administered according to the study protocol. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male participants aged 19 to 55 years.
- Clinical diagnosis of androgenetic alopecia.
- Healthy as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests.
- Willing and able to comply with all study procedures and visit schedules.
Key exclusion criteria (3 listed)
- History or presence of dermatologic conditions affecting the scalp other than androgenetic alopecia.
- Prior hair transplantation or scalp surgery that may affect evaluation of hair growth.
- Use of medications known to affect hair growth (e.g., finasteride, dutasteride, minoxidil) within 6 months prior to screening.
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 |
|---|---|---|
| AD-303ATopical AD-303A applied to the scalp according to the study protocol. | Drug | AD-303A Topical |
| AD-3031Oral AD-3031 administered according to the study protocol. | Drug | Oral AD-3031 |
Primary outcome
Maximum observed plasma concentration (Cmax) of dutasteride
Time frame: Up to Day14
The maximum observed plasma concentration (Cmax) of dutasteride following administration of the study drug.
1 secondary outcome
Change from baseline in scalp dihydrotestosterone (DHT) concentration Description
Time frame: Baseline to Day 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No. Phase 1/2a
Related trials for Androgenetic Alopecia
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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.
Seung Hwan Lee, Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AD-303A and AD-3031 in people with Androgenetic Alopecia, run by Moogene Medi Co., Ltd at 1 site in South Korea.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 24 Mar 2026. 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 South Korea. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ji-Hye Lee, Ph.D. (82-31-8027-6150, jhlee@moogene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) of dutasteride (time frame: Up to Day14). 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 24 Mar 2026.