Study of EPI-001 in Patients With Androgenetic Alopecia

NCT07618195 | Recruiting Phase 1

• 1 other identifier: EPI-001-A101
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Androgenetic Alopecia

Keywords

Hair Loss; Alopecia; Autologous Cell Therapy; Hair Regeneration; Dermal Papilla Cell; Cell therapy

Outcome Measures

Primary Outcomes (1)

• Incidence of Dose-Limiting Toxicities

  Up to 4 weeks after administration

Secondary Outcomes (8)

• Incidence of Adverse Events and Local Adverse Events

  Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration

• Number of Participants With Clinically Significant Abnormal Vital Signs

  Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration

• Number of Participants With Clinically Significant Laboratory Abnormalities

  Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration

• Investigator Assessment of Hair Growth Improvement Based on Clinical Photographs Using a 7-Point Scale

  Phase I: Weeks 4, 12, and 24; Phase IIa: Weeks 12, 24, 36, and 48

• Subject Self-Assessment of Hair Growth Improvement Using a 7-Point Questionnaire Scale

  Phase I: Weeks 4, 12, and 24; Phase IIa: Weeks 12, 24, 36, and 48

Study Arms (2)

EPI-001

EXPERIMENTAL

Biological: EPI-001

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

EPI-001 BIOLOGICAL

EPI-001 is an autologous dermal papilla cell-based investigational product administered by subcutaneous injection to the scalp for the treatment of androgenetic alopecia.

EPI-001

Placebo OTHER

Placebo control administered by subcutaneous injection to the scalp.

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Subjects positive for HBV, HCV, HIV, or syphilis screening tests
• Subjects with a history of hair transplantation, stem cell therapy, or gene therapy
• Subjects with hypersensitivity related to the investigational product or study procedures
• Pregnant or breastfeeding women
• Subjects who participated in another clinical study within the protocol-defined period
• Subjects judged inappropriate for study participation by the investigator

Sponsors & Collaborators

• Epibiotech: lead

Study Sites (1)

Chung-Ang University Hospital

Seoul, Seoul, 06973, South Korea

RECRUITING

MeSH Terms

Conditions

Alopecia

Interventions

EPI 001

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Epibiotech Clinical Operations

CONTACT

+82-70-4209-0556; info@epibiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study consists of a Phase I open-label dose-escalation portion using a traditional 3+3 design, followed by a randomized, double-blind, placebo-controlled Phase IIa dose-expansion portion with parallel assignment.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 1, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)