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.
None
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.
Parallel
SPOT-mRNA01
Biological/VaccineSPOT-mRNA01 (COL1A1 mRNA-loaded by EVs) ,single-dose subcutaneous injection
Placebo
Other interventionSterile 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.
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
Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01
Detecting local skin thickness in injection site biopsy by Masson trichrome stain.
Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01
Detecting local skin thickness by Skin ultrasound.
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SIPO Biotechnology Co. Ltd.
Lead sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
