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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
SPOT-mRNA01 (COL1A1 mRNA-loaded by EVs) ,single-dose subcutaneous injection
Sterile isotonic solution, subcutaneous injection
Assessment of the frequency and severity of AEs caused by SPOT-mRNA01
The investigator will collect a description of the events, time of onset and resolution, assessment of severity and causal relationship to SPOT-mRNA01.
Time frame: 3 months
level of COL1A1 protein expression in local dermal tissue after subcutaneous injection of SPOT-mRNA01
Local collagen expression in injection area biopsy by ELISA detection
Time frame: Days 4, 7 and 31
Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01
Detecting local skin thickness in injection site biopsy by Masson trichrome stain.
Time frame: Days 4, 7 and 31
Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01
Detecting local skin thickness by Skin ultrasound.
Time frame: Baseline and days 7, 15, 31, 61 and 91
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