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Safety of Topical Exosome-Containing Liquid in Healthy Volunteers (EV-SAFE-1)

12 lipca 2026 zaktualizowane przez: Amin Tamadon, West Kazakhstan Marat Ospanov Medical University

A Phase 1 Split-Site Pilot Study to Evaluate the Safety and Dermal Tolerability of Topical Exosome-Containing Liquid in Healthy Adult Volunteers

This Phase 1 split-site pilot study will evaluate the safety and dermal tolerability of a topical exosome-containing liquid in 10 healthy adult volunteers. The investigational liquid will be applied to a small defined area of intact skin. A vehicle liquid without exosomes may be applied to a matched contralateral skin site as a control. The study will assess local skin reactions, systemic adverse events, vital signs, clinical laboratory parameters, and feasibility of topical administration. No burn wound or artificial skin wound will be induced in participants in this Phase 1 safety study.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

The investigational product is a sterile topical exosome-containing liquid being developed for future evaluation in burn wound repair. Preclinical in vivo evaluation in murine wound models suggested improved wound closure and better histological organization of repaired skin after topical exosome-containing formulation administration, with the therapeutic effect being more pronounced in the thermal burn model. In the burn model, the exosome-containing formulation group showed faster wound-area reduction, improved epidermal and dermal organization, reduced inflammatory cellularity, and no significant body-weight differences compared with control groups.

This first-in-human Phase 1 study is designed to evaluate safety and dermal tolerability in healthy adult volunteers before the product is tested in patients with burn wounds. No artificial burn wound or skin wound will be created. The investigational liquid will be applied to a small defined area of intact skin according to the protocol-defined dose and schedule. If a split-site design is used, vehicle liquid without exosomes will be applied to a matched contralateral intact skin site as a control. Participants will be monitored for local skin irritation, erythema, edema, pruritus, burning sensation, pain, rash, allergic reaction, systemic adverse events, vital signs, and clinical laboratory abnormalities.

The first two participants will be enrolled as sentinel participants. Safety data through at least 72 hours after first application will be reviewed before enrollment of the remaining participants. The main purpose of the study is to determine whether topical administration of the exosome-containing liquid is safe and tolerable on intact human skin.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

10

Faza

  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

  • Nazwa: Amin Tamadon, PhD
  • Numer telefonu: +7 705 629 9350
  • E-mail: tamadon@zkmu.kz

Lokalizacje studiów

  • Kazachstan
    • Aktobe
      • Aktobe, Aktobe, Kazachstan, 030012
        • ATMP center of West Kazakhstan Marat Ospanov Medical University
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • Amin Tamadon, PhD
        • Główny śledczy:
          • Nadiar M Mussin, PhD
        • Główny śledczy:
          • Mahdi Mahdipour, PhD
        • Pod-śledczy:
          • Kulyash R. Zhilisbayeva, MSc
        • Pod-śledczy:
          • Ogay V. Borisovich, PhD
        • Pod-śledczy:
          • Nader Tanideh, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

Inclusion Criteria:

  1. Healthy adult volunteers aged 18 to 55 years.
  2. Able and willing to provide written informed consent.
  3. No clinically significant abnormality based on medical history, physical examination, vital signs, and screening laboratory tests.
  4. Intact healthy skin at the planned application sites.
  5. Willingness to avoid applying other topical products, cosmetics, antiseptics, or irritant substances to the application sites during the study period.
  6. Willingness to avoid excessive sun exposure, sauna, swimming pool use, and mechanical irritation of the application sites during the study period.
  7. Willingness to comply with all study visits, topical application procedures, local skin assessments, skin photography, safety assessments, and follow-up.
  8. For women of childbearing potential, a negative pregnancy test before first application and willingness to use an acceptable method of contraception during the study period.

Exclusion Criteria:

  1. Any active skin disease, dermatitis, eczema, psoriasis, urticaria, acneiform eruption, skin infection, open wound, scar, tattoo, burn scar, pigmentation disorder, or clinically significant skin abnormality at the planned application sites.
  2. History of severe allergy, anaphylaxis, or hypersensitivity to topical liquids, dressings, biological products, exosome-containing products, or any component of the investigational product or vehicle liquid.
  3. Current acute illness, fever, or active infection.
  4. Known autoimmune disease, immunodeficiency, or current systemic immunosuppressive therapy.
  5. Use of systemic corticosteroids, immunomodulatory drugs, biological agents, or investigational products within 30 days before enrollment.
  6. Use of topical corticosteroids, topical immunomodulators, topical antibiotics, retinoids, keratolytic agents, or other medicated topical products on or near the planned application sites within 14 days before enrollment.
  7. Clinically significant hepatic, renal, cardiovascular, hematologic, endocrine, neurologic, psychiatric, or systemic disease that may increase risk or interfere with interpretation of study results.
  8. Known active malignancy or history of malignancy within the past 5 years.
  9. Positive screening test for clinically relevant transmissible infection, if required by the protocol.
  10. Pregnancy or breastfeeding.
  11. Positive pregnancy test at screening or before first application in women of childbearing potential.
  12. Participation in another interventional clinical trial within 30 days before enrollment.
  13. Blood donation or major blood loss within 30 days before enrollment, if laboratory safety monitoring is included in the protocol.
  14. Any condition that, in the investigator's judgment, would make participation unsafe or interfere with interpretation of study results.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Exosome-Containing Liquid and Vehicle-Control Skin Sites
Healthy adult volunteers will receive topical exosome-containing liquid applied to a small defined area of intact skin. In the split-site design, vehicle liquid without exosomes will be applied to a matched contralateral intact skin site as a control. No burn wound or artificial skin wound will be induced.
Biologiczny: Exosome-Containing Liquid
The investigational product is a sterile topical liquid containing exosome-enriched extracellular vesicles derived from [insert cell source, e.g., mesenchymal stromal cells]. The liquid will be applied topically to a small defined area of intact skin at a dose of [insert exact dose, e.g., X mL/cm² containing Y particles/mL, equivalent to Z particles/cm²] according to the protocol-defined schedule. The product is investigational and is being evaluated for safety and dermal tolerability before future testing in patients with burn wounds.
Inne nazwy:
  • Extracellular vesicle-containing liquid
  • EV-containing liquid
  • Exosome-enriched extracellular vesicle liquid
  • MSC-derived extracellular vesicle liquid
Inny: Vehicle Liquid
Vehicle liquid without exosomes will be applied topically to a matched contralateral intact skin site according to the same protocol-defined schedule as the exosome-containing liquid. The vehicle liquid is used as a within-participant control for local dermal tolerability assessment.
Inne nazwy:
  • Vehicle control liquid
  • Liquid without exosomes

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants With Treatment-Emergent Adverse Events
Ramy czasowe: From first application through Day 28
Number of participants with any treatment-emergent adverse event after topical application of the exosome-containing liquid. Events include local application-site reactions such as erythema, edema, pruritus, burning sensation, pain, rash, vesicles, ulceration, allergic reaction, or infection, and systemic events such as fever, malaise, abnormal vital signs, clinically significant laboratory abnormalities, serious adverse events, or any other clinically significant adverse event judged by the investigator.
From first application through Day 28

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Maximum Total Score on the Draize Dermal Irritation Scale at the Exosome-Containing Liquid Application Site
Ramy czasowe: Baseline, 30 minutes, 24 hours, 48 hours, 72 hours, Day 7, Day 14, and Day 28
The Draize Dermal Irritation Scale grades erythema and eschar formation from 0, indicating no erythema, to 4, indicating severe erythema or eschar formation, and edema from 0, indicating no edema, to 4, indicating severe edema. The total score is the sum of the erythema/eschar score and edema score and ranges from 0 to 8. Higher scores indicate worse local skin irritation. The maximum total score observed at the exosome-containing liquid application site will be reported.
Baseline, 30 minutes, 24 hours, 48 hours, 72 hours, Day 7, Day 14, and Day 28
Within-Participant Difference in Total Draize Dermal Irritation Scale Score Between Exosome-Containing Liquid and Vehicle-Control Sites
Ramy czasowe: Baseline, 30 minutes, 24 hours, 48 hours, 72 hours, Day 7, Day 14, and Day 28
The within-participant difference will be calculated as the total Draize Dermal Irritation Scale score at the exosome-containing liquid application site minus the total score at the vehicle-control liquid application site at each assessment time point. The total Draize score ranges from 0 to 8, with higher scores indicating worse local skin irritation. Positive values indicate higher irritation at the exosome-containing liquid site, and negative values indicate higher irritation at the vehicle-control site.
Baseline, 30 minutes, 24 hours, 48 hours, 72 hours, Day 7, Day 14, and Day 28
Number of Participants With Clinically Significant Vital Sign Abnormalities
Ramy czasowe: From first application through Day 28
Number of participants with any clinically significant abnormality in vital signs after topical application of the exosome-containing liquid. Vital signs include systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and body temperature. Clinical significance will be determined by the investigator using protocol-defined reference ranges and clinical judgment. The reporting unit is number of participants.
From first application through Day 28
Number of Participants With Clinically Significant Clinical Laboratory Abnormalities
Ramy czasowe: From first application through Day 28
Number of participants with any clinically significant abnormality in clinical laboratory safety tests after topical application of the exosome-containing liquid. Laboratory safety tests include complete blood count, renal function tests, liver function tests, and inflammatory markers according to the protocol. Clinical significance will be determined by the investigator using protocol-defined reference ranges and clinical judgment. The reporting unit is number of participants.
From first application through Day 28
Percentage of Planned Topical Applications Completed According to Protocol
Ramy czasowe: From Day 0 through Day 14
For each participant, the topical application completion percentage will be calculated as the number of completed topical applications divided by the number of protocol-planned topical applications, multiplied by 100. The outcome will be reported as the mean percentage of planned topical applications completed across participants. A higher percentage indicates better feasibility of topical application.
From Day 0 through Day 14
Number of Participants With Delayed Treatment-Emergent Adverse Events
Ramy czasowe: From Day 29 through Day 56
Number of participants with delayed local or systemic treatment-emergent adverse events occurring after completion of the primary Day 28 safety assessment. Delayed events may include local skin reactions, allergic reactions, infection, abnormal vital signs, clinically significant laboratory abnormalities, serious adverse events, or any other clinically significant adverse event judged by the investigator.
From Day 29 through Day 56

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

West Kazakhstan Marat Ospanov Medical University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2026

Ukończenie studiów (Szacowany)

1 stycznia 2027

Daty rejestracji na studia

Pierwszy przesłany

7 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 lipca 2026

Pierwszy wysłany (Rzeczywisty)

15 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • WKMU-EV-SAFE-001
  • IRN BR25593457 (Inny numer grantu/finansowania: Ministry of Healthcare of the Republic of Kazakhstan)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

No. Individual participant data will not be shared because this is a small Phase 1 first-in-human safety and dermal tolerability study in 10 healthy volunteers, and de-identified individual-level data may still carry a risk of participant re-identification. Aggregate study results, adverse event summaries, and protocol-defined outcome summaries may be reported in ClinicalTrials.gov and in peer-reviewed publications.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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