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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
EPI-001
Biological/VaccineEPI-001 is an autologous dermal papilla cell-based investigational product administered by subcutaneous injection to the scalp for the treatment of androgenetic alopecia.
Placebo
Other interventionPlacebo control administered by subcutaneous injection to the scalp.
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: EPI-001Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Dose-Limiting Toxicities
Time frame
Up to 4 weeks after administrationSecondary outcomes
1
Incidence of Adverse Events and Local Adverse Events
Time frame
Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration2
Number of Participants With Clinically Significant Abnormal Vital Signs
Clinically significant abnormal vital signs include abnormalities in systolic blood pressure, diastolic blood pressure, pulse rate, and body temperature.
Time frame
Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration3
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame
Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration4
Investigator Assessment of Hair Growth Improvement Based on Clinical Photographs Using a 7-Point Scale
Investigators assess hair growth improvement by comparing clinical photographs with baseline photographs using a 7-point scale ranging from -3 (greatly decreased) to +3 (greatly increased). Higher scores indicate greater improvement.
Time frame
Phase I: Weeks 4, 12, and 24; Phase IIa: Weeks 12, 24, 36, and 48 Source ClinicalTrials.gov