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RECRUITING
NCT07618195
PHASE1/PHASE2

Study of EPI-001 in Patients With Androgenetic Alopecia

Sponsor: Epibiotech

View on ClinicalTrials.gov

Summary

This is a Phase I/IIa clinical study to evaluate the safety, tolerability, and preliminary efficacy of EPI-001 in patients with androgenetic alopecia. In the Phase I portion, a traditional 3+3 dose-escalation design will be used to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of EPI-001. Subjects will be followed for up to 24 weeks after administration. In the Phase IIa portion, subjects will be randomized in a 2:1 ratio to receive either EPI-001 or placebo. Safety and efficacy will be evaluated through hair count assessment, hair diameter measurement, clinical photography, investigator assessment, expert panel assessment, and subject self-assessment during a follow-up period of up to 48 weeks.

Official title: Phase I/IIa Study to Evaluate the Safety, Tolerability, and Efficacy of EPI-001 in Patients With Androgenetic Alopecia

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2026-01-12

Completion Date

2029-06-01

Last Updated

2026-06-01

Healthy Volunteers

No

Interventions

BIOLOGICAL

EPI-001

EPI-001 is an autologous dermal papilla cell-based investigational product administered by subcutaneous injection to the scalp for the treatment of androgenetic alopecia.

OTHER

Placebo

Placebo control administered by subcutaneous injection to the scalp.

Locations (1)

Chung-Ang University Hospital

Seoul, Seoul, South Korea