此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Study of EPI-001 in Patients With Androgenetic Alopecia

2026年5月26日 更新者：Epibiotech

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

42

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Epibiotech Clinical Operations
  • 电话号码：+82-70-4209-0556
  • 邮箱：info@epibiotech.com

学习地点

  • 韩国
    • Seoul
      • Seoul、Seoul、韩国、06973
        • 招聘中
        • Chung-Ang University Hospital
        • 接触：
          • Chung-Ang University Hospital
          • 电话号码：+82-1800-1114
        • 首席研究员：
          • Beom Joon Kim, MD, PhD.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Male or female subjects aged 19 years or older
  2. Subjects diagnosed with androgenetic alopecia
  3. Subjects willing to maintain the same hairstyle, hair length, and hair color during the study period
  4. Subjects willing to refrain from prohibited hair-related products or procedures during the study period
  5. Subjects willing to undergo scalp tattooing and hair trimming for phototrichogram evaluation
  6. Subjects who voluntarily signed written informed consent

Exclusion Criteria:

  1. Subjects who used prohibited medications or therapies affecting hair growth within the protocol-defined period
  2. Subjects with scalp diseases or hair disorders other than androgenetic alopecia
  3. Subjects with autoimmune diseases affecting the scalp or hair
  4. Subjects with clinically significant cardiovascular, renal, endocrine, infectious, or systemic diseases
  5. Subjects positive for HBV, HCV, HIV, or syphilis screening tests
  6. Subjects with a history of hair transplantation, stem cell therapy, or gene therapy
  7. Subjects with hypersensitivity related to the investigational product or study procedures
  8. Pregnant or breastfeeding women
  9. Subjects who participated in another clinical study within the protocol-defined period
  10. Subjects judged inappropriate for study participation by the investigator

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
其他：Placebo
Placebo control administered by subcutaneous injection to the scalp.
实验性的：EPI-001
生物：EPI-001
EPI-001 is an autologous dermal papilla cell-based investigational product administered by subcutaneous injection to the scalp for the treatment of androgenetic alopecia.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Incidence of Dose-Limiting Toxicities
大体时间：Up to 4 weeks after administration
Up to 4 weeks after administration

次要结果测量

结果测量
措施说明
大体时间
Incidence of Adverse Events and Local Adverse Events
大体时间：Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration
Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration
Number of Participants With Clinically Significant Abnormal Vital Signs
大体时间：Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration
Clinically significant abnormal vital signs include abnormalities in systolic blood pressure, diastolic blood pressure, pulse rate, and body temperature.
Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration
Number of Participants With Clinically Significant Laboratory Abnormalities
大体时间：Phase I: up to 24 weeks; Phase IIa: up to 48 weeks after administration
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
大体时间：Phase I: Weeks 4, 12, and 24; Phase IIa: Weeks 12, 24, 36, and 48
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.
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
大体时间：Phase I: Weeks 4, 12, and 24; Phase IIa: Weeks 12, 24, 36, and 48
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.
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
大体时间：Phase I: Week 24; Phase IIa: Weeks 12, 24, and 48
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.
Phase I: Week 24; Phase IIa: Weeks 12, 24, and 48
Change From Baseline in Mean Hair Diameter Assessed by Phototrichogram
大体时间：Phase I: Week 24; Phase IIa: Weeks 12, 24, and 48
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.
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
大体时间：Phase IIa: Weeks 12, 24, 36, and 48
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.
Phase IIa: Weeks 12, 24, 36, and 48

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Epibiotech

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月12日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2029年6月1日

研究注册日期

首次提交

2026年5月20日

首先提交符合 QC 标准的

2026年5月26日

首次发布 (实际的)

2026年6月1日

研究记录更新

最后更新发布 (实际的)

2026年6月1日

上次提交的符合 QC 标准的更新

2026年5月26日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • EPI-001-A101

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅