Dose Regimen Study of SLI-F06 in Healthy Volunteers

Eligibility Criteria

• 1. Healthy subjects, male or female, ages 18 to 65
• 2. Subjects with a Body Mass Index (BMI) 18.5-30 and at least 40 kg
• 3. Subjects with symmetrically located right and left scapular lines relative to the midline, and at least 12 cm distance between the right and left scapular lines.
• 4. Be able to follow study instructions and likely to complete all required visits.
• 5. Sign the Institutional Review Board (IRB)-approved informed consent form (ICF, which includes the Photographic and Video Release Form) prior to any study-related procedures being performed.
• 1. Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control methods
• 2. Subjects who were previously treated with SLI-F06
• 3. Subjects with evidence of hypertrophic or keloid scarring
• 4. Subjects with obvious back abnormalities (e.g., severe scoliosis)
• 5. Subjects with tattoos or previous scars in the study areas
• 6. Subjects who are poor surgical candidates
• 1. Active disease that could interfere with or limit wound healing (e.g., diabetes, anemia, renal disease, hepatic disease, cardiac disease, or immune system disorders)
• 2. History of clinically significant bleeding disorder or coagulation disorders
• 3. Use of any tobacco/inhaled nicotine products including vaping within 12 months.
• 7. Subjects with evidence of skin infection or rash on the back
• 8. Subjects with history of active or uncontrolled skin disease (e.g., psoriasis, eczema, rosacea, vitiligo, skin cancer) that could interfere with the study or interpretation of the study outcomes
• 9. Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine or allergy to adhesive surgical dressings
• 10. Subjects with any clinically significant abnormality following review of pre-study laboratory data and full physical examination
• 11. Subjects who are taking or have taken known anticoagulants:
• 1. Blood thinners (e.g., coumadin, rivaroxaban, apixaban) within 2 months prior to day 0
• 2. Others such as aspirin or aspirin containing products, Non-steroidal anti-inflammatory drugs (NSAIDs), vitamin E, fish oil within 14 days prior to day 0.
• 12. Subjects taking systemic or topical steroids within 4 weeks of Day 0
• 13. Subjects with excessive alcohol use, defined as \>28 units of alcohol per week (1unit = 8 g alcohol, 1shot spirits, half- pint beer, or 5 oz wine)
• 14. Subjects who have evidence of drug abuse
• 15. Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen per medical history
• 16. Subjects with a history of poor or delayed wound healing (e.g., prior wound dehiscence, chronic wound, leg ulcer)
• 17. Subjects treated with an investigational drug or device within 30 days prior to day 0
• 18. Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, or may significantly interfere with the subject's participation in the study