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

Launched by SIPO BIOTECHNOLOGY CO. LTD. · Aug 19, 2024

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ClinConnect Summary

This clinical trial, called the Preliminary Evaluation of the Safety and Tolerability of SPOT-mRNA01, is looking at a new injection meant to help with skin aging. The study will involve healthy adults aged between 18 and 75 years, who will receive either the SPOT-mRNA01 injection or a placebo (a dummy treatment with no active ingredients) to see how safe and well-tolerated the injection is. It’s a first-time test in people, which means researchers are gathering important information on how this treatment affects individuals.

To participate, volunteers must be generally healthy and not have certain skin conditions or recent cosmetic treatments that could affect the results. They also should not have a history of serious allergic reactions or other specific health issues. Those who join the study can expect to receive either the treatment or placebo, and will be closely monitored for any side effects. It's important to know that the trial is not yet recruiting participants, so interested individuals will need to wait for further announcements.

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.