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| Name | Class |
|---|---|
| Seoul National University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD-303A Topical | Experimental | Participants receive topical AD-303A applied to the scalp according to the study protocol. |
|
| Oral AD-3031 | Active Comparator | Participants receive oral AD-3031 administered according to the study protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD-303A | Drug | Topical AD-303A applied to the scalp according to the study protocol. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of dutasteride | The maximum observed plasma concentration (Cmax) of dutasteride following administration of the study drug. | Up to Day14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
Gender Eligibility Description
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ji-Hye Lee, Ph.D. | Contact | 82-31-8027-6150 | jhlee@moogene.com | |
| Tae-Jong Yoon, Ph.D. | Contact | 82-31-8027-6150 | moogenemedi@moogene.com |
| Name | Affiliation | Role |
|---|---|---|
| Seung Hwan Lee, Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Seoul | 03080 | South Korea |
Phase 1/2a
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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.
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Allocation, Randomized, Open label
| AD-3031 |
| Drug |
Oral AD-3031 administered according to the study protocol. |
|
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |