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

What this Trial Is About

Researchers are evaluating EPI-001, an autologous dermal papilla cell therapy, for treating androgenetic alopecia, a common form of hair loss in both men and women. This Phase I/IIa clinical trial aims to assess the safety, tolerability, and preliminary effectiveness of EPI-001 in patients with this condition, addressing the need for improved treatment options. The study is sponsored by Epibiotech and involves two parts: a dose-escalation phase and a randomized controlled phase. In the Phase I portion, a traditional 3+3 dose-escalation design will determine the maximum tolerated dose and recommended Phase 2 dose of EPI-001, delivered as a single subcutaneous injection to the scalp. Participants will be followed for up to 24 weeks after administration. In the Phase IIa portion, subjects will be randomly assigned in a 2:1 ratio to receive either EPI-001 at the recommended dose or a placebo injection. This phase includes a follow-up period of up to 48 weeks to evaluate hair growth and safety. Participants will undergo various assessments including hair count and diameter measurements using phototrichograms, clinical photography, and hair growth evaluations by investigators, expert panels, and self-assessment questionnaires. Safety monitoring includes tracking dose-limiting toxicities, adverse events, vital signs, and laboratory tests. The study's primary outcome is the incidence of dose-limiting toxicities within four weeks of administration, with additional safety and efficacy measures tracked throughout the follow-up periods.

Study of EPI-001 in Patients With Androgenetic Alopecia