Study of EPI-001 in Patients With Androgenetic Alopecia
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 2 단계
- 1단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Epibiotech Clinical Operations
- 전화번호: +82-70-4209-0556
- 이메일: info@epibiotech.com
연구 장소
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Seoul
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Seoul, Seoul, 대한민국, 06973
- 모병
- Chung-Ang University Hospital
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연락하다:
- Chung-Ang University Hospital
- 전화번호: +82-1800-1114
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수석 연구원:
- Beom Joon Kim, MD, PhD.
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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위약 비교기: 위약
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Placebo control administered by subcutaneous injection to the scalp.
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실험적: EPI-001
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EPI-001 is an autologous dermal papilla cell-based investigational product administered by subcutaneous injection to the scalp for the treatment of androgenetic alopecia.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Incidence of Dose-Limiting Toxicities
기간: Up to 4 weeks after administration
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Up to 4 weeks after administration
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Adverse Events and Local Adverse Events
기간: Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration
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Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration
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Number of Participants With Clinically Significant Abnormal Vital Signs
기간: Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration
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Clinically significant abnormal vital signs include abnormalities in systolic blood pressure, diastolic blood pressure, pulse rate, and body temperature.
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Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration
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Number of Participants With Clinically Significant Laboratory Abnormalities
기간: Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration
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Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration
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Investigator Assessment of Hair Growth Improvement Based on Clinical Photographs Using a 7-Point Scale
기간: Phase I: Weeks 4, 12, and 24; Phase IIa: Weeks 12, 24, 36, and 48
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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.
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Phase I: Weeks 4, 12, and 24; Phase IIa: Weeks 12, 24, 36, and 48
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Subject Self-Assessment of Hair Growth Improvement Using a 7-Point Questionnaire Scale
기간: Phase I: Weeks 4, 12, and 24; Phase IIa: Weeks 12, 24, 36, and 48
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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.
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Phase I: Weeks 4, 12, and 24; Phase IIa: Weeks 12, 24, 36, and 48
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Change From Baseline in Total Hair Count Assessed by Phototrichogram
기간: Phase I: Week 24; Phase IIa: Weeks 12, 24, and 48
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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.
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Phase I: Week 24; Phase IIa: Weeks 12, 24, and 48
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Change From Baseline in Mean Hair Diameter Assessed by Phototrichogram
기간: Phase I: Week 24; Phase IIa: Weeks 12, 24, and 48
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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.
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Phase I: Week 24; Phase IIa: Weeks 12, 24, and 48
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Expert Panel Assessment of Hair Growth Improvement Based on Clinical Photographs Using a 7-Point Scale
기간: Phase IIa: Weeks 12, 24, 36, and 48
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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.
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Phase IIa: Weeks 12, 24, 36, and 48
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- EPI-001-A101
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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