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Study of EPI-001 in Patients With Androgenetic Alopecia

RecruitingPhase 1, Phase 2Ages 19 Years - anyAllEpibiotech
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • EPI-001
  • Placebo
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Where

1 site
Chung-Ang University Hospital
Seoul, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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