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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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

42

段階

  • フェーズ2
  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Epibiotech Clinical Operations
  • 電話番号：+82-70-4209-0556
  • メール：info@epibiotech.com

研究場所

  • 韓国
    • Seoul
      • Seoul、Seoul、韓国、06973
        • 募集
        • Chung-Ang University Hospital
        • コンタクト：
          • Chung-Ang University Hospital
          • 電話番号：+82-1800-1114
        • 主任研究者：
          • Beom Joon Kim, MD, PhD.

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：プラセボ
他の：Placebo
Placebo control administered by subcutaneous injection to the scalp.
実験的：EPI-001
生物学的：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
時間枠
Incidence of Dose-Limiting Toxicities
時間枠：Up to 4 weeks after administration
Up to 4 weeks after administration

二次結果の測定

結果測定
メジャーの説明
時間枠
Incidence of Adverse Events and Local Adverse Events
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Epibiotech

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年1月12日

一次修了 (推定)

2028年6月1日

研究の完了 (推定)

2029年6月1日

試験登録日

最初に提出

2026年5月20日

QC基準を満たした最初の提出物

2026年5月26日

最初の投稿 (実際)

2026年6月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月1日

QC基準を満たした最後の更新が送信されました

2026年5月26日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • EPI-001-A101

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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