Assessment of Dutasteride Topical Solution in Male Androgenetic Alopecia

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.