Study of EPI-001 in Patients With Androgenetic Alopecia

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Androgenetic Alopecia

In brief

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.

Key facts

Study ID

NCT07618195

Run by

Epibiotech

People needed

42

Starts

2026-01-12

Expected to finish

2029-06-01

Last updated by the study team

2026-06-01

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects aged 19 years or older
• Subjects diagnosed with androgenetic alopecia
• Subjects willing to maintain the same hairstyle, hair length, and hair color during the study period
• Subjects willing to refrain from prohibited hair-related products or procedures during the study period
• Subjects willing to undergo scalp tattooing and hair trimming for phototrichogram evaluation
• Subjects who voluntarily signed written informed consent

You may not qualify if…

• Subjects who used prohibited medications or therapies affecting hair growth within the protocol-defined period
• Subjects with scalp diseases or hair disorders other than androgenetic alopecia
• Subjects with autoimmune diseases affecting the scalp or hair
• Subjects with clinically significant cardiovascular, renal, endocrine, infectious, or systemic diseases
• Subjects positive for HBV, HCV, HIV, or syphilis screening tests
• Subjects with a history of hair transplantation, stem cell therapy, or gene therapy
• Subjects with hypersensitivity related to the investigational product or study procedures
• Pregnant or breastfeeding women
• Subjects who participated in another clinical study within the protocol-defined period
• Subjects judged inappropriate for study participation by the investigator

Where it is running

• Chung-Ang University Hospital — Seoul, Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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