Condition: Androgenetic Alopecia · Sponsor: Epibiotech
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.
This description comes directly from the study's public registry record.
Epibiotech Clinical Operations · +82-70-4209-0556 · info@epibiotech.com
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| Chung-Ang University Hospital | Seoul, Seoul, South Korea | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07618195