Preliminary Evaluation of the Safety and Tolerability of SPOT-mRNA01 Subcutaneously Administered in Healthy Subjects

Официальное название

A Randomized, Double-blind, Placebo-controlled Exploratory Clinical Study to Evaluate the Safety and Tolerability of SPOT-mRNA01 Injection in Healthy Adult Subjects.

Обзор

This is a first-in-human, randomized, double-blind, placebo-controlled clinical study to evaluate the Safety and Tolerability of SPOT-mRNA01 injection in healthy adult volunteers.

Подробное описание

SPOT-mRNA01 (collagen 1 alpha 1 (COL1A1) mRNA-loaded by Extracellular vesicles （EVs）) can induce collagen protein grafts in dermal tissue, thereby supplementing collagen and reducing wrinkle formation in collagen-depleted skin. Therefore, SPOTmRNA01 can provide a source of human collagen intradermally for cosmetic anti-aging use.

This is a first-in-human randomized, double-blind, placebo-controlled, single-dose, dose ascending, exploratory clinical study to evaluate the Safety and Tolerability of SPOT-mRNA01 administered by subcutaneous injection to healthy adult volunteers.

Biopsies will be used to detect the expression of collagen in the skin of the injection area.

Вмешательства

• Биопрепарат SPOT-mRNA01
  SPOT-mRNA01 (COL1A1 mRNA-loaded by EVs) ,single-dose subcutaneous injection
• Другое Placebo
  Sterile isotonic solution, subcutaneous injection

Первичные конечные точки

• Assessment of the frequency and severity of AEs caused by SPOT-mRNA01 [Срок оценки: 3 months]

Вторичные конечные точки (3)

• level of COL1A1 protein expression in local dermal tissue after subcutaneous injection of SPOT-mRNA01 [Срок оценки: Days 4, 7 and 31]
• Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01 [Срок оценки: Days 4, 7 and 31]
• Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01 [Срок оценки: Baseline and days 7， 15， 31， 61 and 91]

Критерии участия

Критерии включения

Aged 18 to 75 years inclusive at the time of informed consent.

Критерии исключения

• Any transient or chronic skin condition, disorder, or infection within 20 cm of the target areas before treatment that, in the opinion of the investigator, may confound study results.
• History of laser treatment or chemical peels or any cosmetic anti-aging treatments to the target areas within six months of the study treatment.
• History of surgical procedures to target areas, including removal of benign or malignant skin cancers that, in the opinion of the investigator, may confound study results.
• Participant with a history of heavy smoking, alcohol or drug abuse or steroid treatment.
• Pregnant or breast-feeding females.
• History of anaphylaxis or allergic reactions to any constituent of the study product and/or local anesthetics, and/or history of severe abnormal drug reaction.
• Those who have participated in clinical trials of other investigational drugs within 3 months before the study treatment.
• Those who are not suitable for subcutaneous injection and biopsy.
• Any condition that the investigator or primary physician believes may not be appropriate for participating the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06567119 · FM-T1-SH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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