Androgenetic AlopeciaPhase 1/2NCT07618195
Study of EPI-001 in Patients With Androgenetic Alopecia
A Phase 1/2 study testing EPI-001 in people with Androgenetic Alopecia, run by Epibiotech at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- EPI-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jan 2026to 1 Jun 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Chung-Ang University Hospital
Seoul, Seoul, 06973
Chung-Ang University Hospital, +82-1800-1114
Beom Joon Kim, MD, PhD.
About this study
Official title: 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.
Read the detailed description
Androgenetic alopecia (AGA) is one of the most common forms of hair loss in both men and women and is characterized by progressive hair follicle miniaturization associated with androgen sensitivity and genetic predisposition. Current treatment options for AGA are limited and may not provide sufficient therapeutic benefit for all patients.
EPI-001 is an autologous dermal papilla cell therapy intended for the treatment of androgenetic alopecia. This study is designed to evaluate the safety, tolerability, and efficacy of EPI-001 in subjects with androgenetic alopecia.
This study consists of two parts: a Phase I dose-escalation study and a Phase IIa dose-expansion study.
In the Phase I portion, subjects will receive a single administration of EPI-001 using a traditional 3+3 dose-escalation design to evaluate dose-limiting toxicity (DLT), determine the maximum tolerated dose (MTD), and establish the recommended Phase 2 dose (RP2D). Subjects will be followed for up to 24 weeks after administration.
In the Phase IIa portion, eligible subjects will be randomized in a 2:1 ratio to receive either EPI-001 at the RP2D or placebo. The study will evaluate efficacy through changes in total hair count and hair diameter, as well as investigator assessment, expert panel assessment based on clinical photographs, and subject self-assessment questionnaires. Subjects will undergo follow-up assessments for up to 48 weeks after administration.
- Conditions
- Androgenetic Alopecia
- Being tested
- EPI-001, Placebo
- Keywords
- Hair Loss, Alopecia, Autologous Cell Therapy, Hair Regeneration, Dermal Papilla Cell, Cell therapy
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPI-001Biological
EPI-001 is an autologous dermal papilla cell-based investigational product administered by subcutaneous injection to the scalp for the treatment of androgenetic alopecia.
PlaceboOther
Placebo control administered by subcutaneous injection to the scalp.
| Study group | Role | What they receive |
|---|---|---|
| EPI-001 | Experimental | Not described Receives: Biological: EPI-001 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities
Measured: Up to 4 weeks after administration
Secondary outcomes (8)
Incidence of Adverse Events and Local Adverse Events
Measured: Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration
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.
Measured: Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration
Number of Participants With Clinically Significant Laboratory Abnormalities
Measured: 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
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.
Measured: 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
Participants assess overall hair growth improvement using a questionnaire evaluating whether hair became fuller, reduction in hair shedding, increase in hair thickness, improvement in hair gloss and elasticity, improvement in overall scalp appearance, and increase in hair growth rate. Each item is scored on a 7-point scale ranging from -3 (greatly worsened) to +3 (greatly improved). Higher scores indicate greater perceived improvement.
Measured: Phase I: Weeks 4, 12, and 24; Phase IIa: Weeks 12, 24, 36, and 48
Change From Baseline in Total Hair Count Assessed by Phototrichogram
Total hair count is assessed as the number of hairs identified within the target assessment area using phototrichogram imaging. Changes from baseline in total hair count within the target assessment area are evaluated.
Measured: Phase I: Week 24; Phase IIa: Weeks 12, 24, and 48
Change From Baseline in Mean Hair Diameter Assessed by Phototrichogram
Mean hair diameter is assessed by measuring hair shaft thickness within the target assessment area using phototrichogram imaging. Changes from baseline in mean hair diameter are evaluated.
Measured: Phase I: Week 24; Phase IIa: Weeks 12, 24, and 48
Expert Panel Assessment of Hair Growth Improvement Based on Clinical Photographs Using a 7-Point Scale
Expert panel members 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.
Measured: Phase IIa: Weeks 12, 24, 36, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start12 Jan 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epibiotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618195
- Sponsor's protocol ID
- EPI-001-A101
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) collected during the study will not be made publicly available due to the proprietary nature of the investigational product and ongoing clinical development.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIa Study to Evaluate the Safety, Tolerability, and Efficacy of EPI-001 in Patients With Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT07618195
- Acronym / sponsor ID
- EPI-001-A101
- Conditions
- Androgenetic Alopecia
- Keywords
- Hair Loss, Alopecia, Autologous Cell Therapy, Hair Regeneration, Dermal Papilla Cell, Cell therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- EpibiotechIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Androgenetic alopecia (AGA) is one of the most common forms of hair loss in both men and women and is characterized by progressive hair follicle miniaturization associated with androgen sensitivity and genetic predisposition. Current treatment options for AGA are limited and may not provide sufficient therapeutic benefit for all patients.
EPI-001 is an autologous dermal papilla cell therapy intended for the treatment of androgenetic alopecia. This study is designed to evaluate the safety, tolerability, and efficacy of EPI-001 in subjects with androgenetic alopecia.
This study consists of two parts: a Phase I dose-escalation study and a Phase IIa dose-expansion study.
In the Phase I portion, subjects will receive a single administration of EPI-001 using a traditional 3+3 dose-escalation design to evaluate dose-limiting toxicity (DLT), determine the maximum tolerated dose (MTD), and establish the recommended Phase 2 dose (RP2D). Subjects will be followed for up to 24 weeks after administration.
In the Phase IIa portion, eligible subjects will be randomized in a 2:1 ratio to receive either EPI-001 at the RP2D or placebo. The study will evaluate efficacy through changes in total hair count and hair diameter, as well as investigator assessment, expert panel assessment based on clinical photographs, and subject self-assessment questionnaires. Subjects will undergo follow-up assessments for up to 48 weeks after administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| EPI-001 | Experimental | Biological: EPI-001 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPI-001EPI-001 is an autologous dermal papilla cell-based investigational product administered by subcutaneous injection to the scalp for the treatment of androgenetic alopecia. | Biological | EPI-001 |
| PlaceboPlacebo control administered by subcutaneous injection to the scalp. | Other | Placebo |
Primary outcome
Incidence of Dose-Limiting Toxicities
Time frame: Up to 4 weeks after administration
8 secondary outcomes
Incidence of Adverse Events and Local Adverse Events
Time frame: Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration
Number of Participants With Clinically Significant Abnormal Vital Signs
Time frame: Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: 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
Time frame: 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
Time frame: Phase I: Weeks 4, 12, and 24; Phase IIa: Weeks 12, 24, 36, and 48
Change From Baseline in Total Hair Count Assessed by Phototrichogram
Time frame: Phase I: Week 24; Phase IIa: Weeks 12, 24, and 48
Change From Baseline in Mean Hair Diameter Assessed by Phototrichogram
Time frame: Phase I: Week 24; Phase IIa: Weeks 12, 24, and 48
Expert Panel Assessment of Hair Growth Improvement Based on Clinical Photographs Using a 7-Point Scale
Time frame: Phase IIa: Weeks 12, 24, 36, and 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) collected during the study will not be made publicly available due to the proprietary nature of the investigational product and ongoing clinical development.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EPI-001 in people with Androgenetic Alopecia, run by Epibiotech at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Epibiotech Clinical Operations (+82-70-4209-0556, info@epibiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (time frame: Up to 4 weeks after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.