Assessment of Dutasteride Topical Solution in Male Androgenetic Alopecia

NCT07490327 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: AD-303PK
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenetic Alopecia

Keywords

AD-303A / AD-3031; Androgenetic Alopecia; Dutasteride; Topical; 5-Alpha Reductase Inhibitor; Pharmacokinetics; Safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline in scalp dihydrotestosterone (DHT) concentration Description

  Baseline to Day 8

Study Arms (2)

AD-303A Topical

EXPERIMENTAL

Participants receive topical AD-303A applied to the scalp according to the study protocol.

Drug: AD-303A

Oral AD-3031

ACTIVE COMPARATOR

Participants receive oral AD-3031 administered according to the study protocol.

Drug: AD-3031

Interventions

AD-303A DRUG

Topical AD-303A applied to the scalp according to the study protocol.

AD-303A Topical

AD-3031 DRUG

Oral AD-3031 administered according to the study protocol.

Oral AD-3031

Eligibility Criteria

• Age: 19 Years - 55 Years
• Gender Eligibility Details: Gender Eligibility Description
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Moogene Medi Co., Ltd: lead
• Seoul National University Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Seung Hwan Lee, Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Allocation, Randomized, Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)