Dose Regimen Study of SLI-F06 in Healthy Volunteers

The is a Phase IIa dose-regimen study of small punch biopsy scars created on the upper and lower back of healthy patients. All excisions will be randomized to treatment with vehicle or 4 doses of SLI-F06 drug product. Patients will be divided into 3 cohorts, with Cohort B receiving the same doses as Cohort A but daily for a total of 5 days. Cohort C will receive up to twice the concentration of Cohort A potentially divided into 2 doses, with both cohorts treated only on treatment Day 0. Scars will be assessed for improvement by both the investigator and the patient at follow-up visits over 6-9 months.

Duration of study-approximately 7-10 months.

Inclusion criteria

• Healthy subjects, male or female, ages 18 to 65
• Subjects with a Body Mass Index (BMI) 18.5-30 and at least 40 kg
• 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.
• Be able to follow study instructions and likely to complete all required visits.
• 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.

Exclusion criteria

• Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control methods
• Subjects who were previously treated with SLI-F06
• Subjects with evidence of hypertrophic or keloid scarring
• Subjects with obvious back abnormalities (e.g., severe scoliosis)
• Subjects with tattoos or previous scars in the study areas
• Subjects who are poor surgical candidates

• Active disease that could interfere with or limit wound healing (e.g., diabetes, anemia, renal disease, hepatic disease, cardiac disease, or immune system disorders)
• History of clinically significant bleeding disorder or coagulation disorders
• Use of any tobacco/inhaled nicotine products including vaping within 12 months.
• Subjects with evidence of skin infection or rash on the back
• 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
• Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine or allergy to adhesive surgical dressings
• Subjects with any clinically significant abnormality following review of pre-study laboratory data and full physical examination
• Subjects who are taking or have taken known anticoagulants:

• Blood thinners (e.g., coumadin, rivaroxaban, apixaban) within 2 months prior to day 0
• 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.
• Subjects taking systemic or topical steroids within 4 weeks of Day 0
• 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)
• Subjects who have evidence of drug abuse
• Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen per medical history
• Subjects with a history of poor or delayed wound healing (e.g., prior wound dehiscence, chronic wound, leg ulcer)
• Subjects treated with an investigational drug or device within 30 days prior to day 0
• 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