Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPOT-mRNA01 | Active Comparator | SPOT-mRNA01 (COL1A1 mRNA-loaded by EVs) |
|
| Placebo | Placebo Comparator | Sterile isotonic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPOT-mRNA01 | Biological | SPOT-mRNA01 (COL1A1 mRNA-loaded by EVs) ,single-dose subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Days 4, 7 and 31 |
| Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01 |
Not provided
Inclusion Criteria:
Aged 18 to 75 years inclusive at the time of informed consent.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Sterile isotonic solution, subcutaneous injection |
|
Detecting local skin thickness in injection site biopsy by Masson trichrome stain. |
| Days 4, 7 and 31 |
| Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01 | Detecting local skin thickness by Skin ultrasound. | Baseline and days 7, 15, 31, 61 and 91 |