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

This clinical trial is looking at a new treatment called SPOT-mRNA01, which is designed to help with skin aging. The study aims to see if this injection is safe and well-tolerated when given to healthy adults. It is the first time this treatment is being tested in people, and it will involve volunteers aged 18 to 75. Participants will be randomly assigned to receive either the SPOT-mRNA01 injection or a placebo (which looks like the treatment but has no active ingredients) without knowing which one they received.

To be eligible for the trial, participants should be generally healthy and not have any significant skin issues or recent cosmetic treatments on their skin. They also should not have a history of severe allergic reactions or other health conditions that could interfere with the study. For those who join, they can expect to receive the injection and be monitored for any side effects. It's important to note that the study is not yet recruiting participants, so there will be more information available in the future for those interested in taking part.

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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