RecruitingPhase 1Phase 2NCT07618195

Study of EPI-001 in Patients With Androgenetic Alopecia

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

Sponsor

Epibiotech

Enrollment

42 participants

Start Date

Jan 12, 2026

Study Type

INTERVENTIONAL

Conditions

androgenetic alopecia

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.

Eligibility

Min Age: 19 Years

Inclusion Criteria6

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

Exclusion Criteria10

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

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Interventions

BIOLOGICALEPI-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.

OTHERPlacebo

Placebo control administered by subcutaneous injection to the scalp.