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