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Clinical Trial NCT07490327 for Androgenetic Alopecia is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Assessment of Dutasteride Topical Solution in Male Androgenetic Alopecia Phase 1, Phase 2 30 Randomized Open-Label

Not yet recruiting
Clinical Trial NCT07490327 is designed to study Treatment for Androgenetic Alopecia. This Phase 1 Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 1 April 2026 until the study accrues 30 participants. Led by Moogene Medi Co., Ltd, this study is expected to complete by 1 December 2026. The latest data from ClinicalTrials.gov was last updated on 24 March 2026.
Brief 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. The study aims to compare pharmacological characteristics and safety profiles to support dose selection for further clinical development.
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

Conditions
Androgenetic Alopecia
Other Study IDs
  • AD-303PK
NCT ID Number
NCT07490327
Start Date (Actual)
2026-04
Last Update Posted
2026-03-24
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Not yet recruiting
Keywords
AD-303A / AD-3031
Androgenetic Alopecia
Dutasteride
Topical
5-Alpha Reductase Inhibitor
Pharmacokinetics
Safety
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalAD-303A Topical
Participants receive topical AD-303A applied to the scalp according to the study protocol.
AD-303A
Topical AD-303A applied to the scalp according to the study protocol.
Active ComparatorOral AD-3031
Participants receive oral AD-3031 administered according to the study protocol.
AD-3031
Oral AD-3031 administered according to the study protocol.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
19 Years
Eligible Sexes
Male
Accepts Healthy Volunteers
Yes
  • 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.

  • 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.
Moogene Medi Co., Ltd logoMoogene Medi Co., Ltd
Seoul National University Hospital logoSeoul National University Hospital377 active studies to explore
Study Central Contact
Contact: Ji-Hye Lee, Ph.D., 82-31-8027-6150, [email protected]
Contact: Tae-Jong Yoon, Ph.D., 82-31-8027-6150, [email protected]
1 Study Locations in 1 Countries

Seoul

Seoul National University Hospital, Seoul, Seoul, 03080, South Korea
Seung Hwan Lee, Ph.D., Contact, 82-2-2072-2343, [email protected]