Skin Aging
Conditions
Keywords
SPOT-mRNA01, COL1A1 mRNA, EVs
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALSPOT-mRNA01
SPOT-mRNA01 (COL1A1 mRNA-loaded by EVs) ,single-dose subcutaneous injection
OTHERPlacebo
Sterile isotonic solution, subcutaneous injection
Sponsors
SIPO Biotechnology Co. Ltd.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Aged 18 to 75 years inclusive at the time of informed consent.
Exclusion criteria
1. 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. 2. History of laser treatment or chemical peels or any cosmetic anti-aging treatments to the target areas within six months of the study treatment. 3. 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. 4. Participant with a history of heavy smoking, alcohol or drug abuse or steroid treatment. 5. Pregnant or breast-feeding females. 6. 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. 7. Those who have participated in clinical trials of other investigational drugs within 3 months before the study treatment. 8. Those who are not suitable for subcutaneous injection and biopsy. 9. Any condition that the investigator or primary physician believes may not be appropriate for participating the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the frequency and severity of AEs caused by SPOT-mRNA01 | 3 months | The investigator will collect a description of the events, time of onset and resolution, assessment of severity and causal relationship to SPOT-mRNA01. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| level of COL1A1 protein expression in local dermal tissue after subcutaneous injection of SPOT-mRNA01 | Days 4, 7 and 31 | Local collagen expression in injection area biopsy by ELISA detection |
| Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01 | Days 4, 7 and 31 | Detecting local skin thickness in injection site biopsy by Masson trichrome stain. |
Outcome results
None listed