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.
Placebo: Placebo control administered by subcutaneous injection to the scalp.
Study 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
Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Male or female subjects aged 19 years or older
2. Subjects diagnosed with androgenetic alopecia
3. Subjects willing to maintain the same hairstyle, hair length, and hair color during the study period
4. Subjects willing to refrain from prohibited hair-related products or procedures during the study period
5. Subjects willing to undergo scalp tattooing and hair trimming for phototrichogram evaluation
6. Subjects who voluntarily signed written informed consent
Exclusion Criteria:
1. Subjects who used prohibited medications or therapies affecting hair growth within the protocol-defined period
2. Subjects with scalp diseases or hair disorders other than androgenetic alopecia
3. Subjects with autoimmune diseases affecting the scalp or hair
4. Subjects with clinically significant cardiovascular, renal, endocrine, infectious, or systemic diseases
5. Subjects positive for HBV, HCV, HIV, or syphilis screening tests
6. Subjects with a history of hair transplantation, stem cell therapy, or gene therapy
7. Subjects with hypersensitivity related to the investigational product or study procedures
8. Pregnant or breastfeeding women
9. Subjects who participated in another clinical study within the protocol-defined period
10. Subjects judged inappropriate for study participation by the investigator
Primary outcome measure(s)
Incidence of Dose-Limiting Toxicities — Up to 4 weeks after administration
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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