NCT07618195 Study of EPI-001 in Patients With Androgenetic Alopecia
| NCT ID | NCT07618195 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Epibiotech |
| Condition | Androgenetic Alopecia |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2026-01-12 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2026-01-12 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07618195 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Androgenetic Alopecia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07618195 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07618195 currently recruiting?
Yes, NCT07618195 is actively recruiting participants. Contact the research team at info@epibiotech.com for enrollment information.
Where is the NCT07618195 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07618195 clinical trial?
NCT07618195 is sponsored by Epibiotech. The trial plans to enroll 42 participants.