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Study of EPI-001 in Patients With Androgenetic Alopecia

26 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

42

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Epibiotech Clinical Operations
  • Numero di telefono: +82-70-4209-0556
  • Email: info@epibiotech.com

Luoghi di studio

  • Corea del Sud
    • Seoul
      • Seoul, Seoul, Corea del Sud, 06973
        • Reclutamento
        • Chung-Ang University Hospital
        • Contatto:
          • Chung-Ang University Hospital
          • Numero di telefono: +82-1800-1114
        • Investigatore principale:
          • Beom Joon Kim, MD, PhD.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Altro: Placebo
Placebo control administered by subcutaneous injection to the scalp.
Sperimentale: EPI-001
Biologico: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Incidence of Dose-Limiting Toxicities
Lasso di tempo: Up to 4 weeks after administration
Up to 4 weeks after administration

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Adverse Events and Local Adverse Events
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Epibiotech

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 gennaio 2026

Completamento primario (Stimato)

1 giugno 2028

Completamento dello studio (Stimato)

1 giugno 2029

Date di iscrizione allo studio

Primo inviato

20 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 maggio 2026

Primo Inserito (Effettivo)

1 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • EPI-001-A101

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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