Study of EPI-001 in Patients With Androgenetic Alopecia
ConditionAndrogenetic Alopecia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorEpibiotech
About this trial
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
Qualifiers
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
Disqualifiers
Subjects who used prohibited medications or therapies affecting hair growth within the protocol-defined period
Subjects with scalp diseases or hair disorders other than androgenetic alopecia
Subjects with autoimmune diseases affecting the scalp or hair
Subjects with clinically significant cardiovascular, renal, endocrine, infectious, or systemic diseases
Trial design
Treatments tested in this trial
- EPI-001
- Placebo
Treatment groups
42 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov