Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Androgenic Alopecia

Treatments: Drug: DA-4001 L; Drug: DA-4001 H

Study type: Interventional

Funder types: Industry

Identifiers

NCT02824380

DA4001_AGAP_I

Details and patient eligibility

About

An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects with Androgenic Alopecia.

Enrollment: 14 patients

Sex: Male

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male, aged between 19 and 65 years, clinically healthy
• BMI between 18.5kg/m2 and 27kg/m2
• Clinical history of Androgenic Alopecia

Exclusion criteria

• Subject has any dermatological disorders of the scalp
• Subject has a history of hair transplants, hair weaves
• Subject has hypersensitivity to previously prescribed minoxidil or finasteride
• Subject who is considered inappropriate to participate in the study due to any conditions including screening results at the investigator's discretion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

14 participants in 2 patient groups

Sequence A

Experimental group

Description:

Period 1: DA-4001 H(High dose) Period 2: DA-4001 L(Low dose)

Treatment:

Drug: DA-4001 H

Drug: DA-4001 L

Sequence B

Experimental group

Description:

Period 1: DA-4001 L(Low dose) Period 2: DA-4001 H(High dose)

Treatment:

Drug: DA-4001 H

Drug: DA-4001 L