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

Launched by SPOT BIOSYSTEMS LTD. · May 30, 2024

Keywords

ClinConnect Summary

SPOT-mRNA01 (collagen 1 alpha 1 (COL1A1) mRNA-loaded EVs) can induce collagen protein grafts in dermal tissue, thereby supplementing collagen and reducing wrinkle formation in collagen-depleted skin. Therefore, SPOT-mRNA01 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.

Gender

ALL

Eligibility criteria

• 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.
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