Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants

The study will contain four, single ascending dose-escalation cohorts and four multiple dose-escalation cohorts allowing an exploration of different doses of SOF-SKN with safety monitoring to ensure the safety of the participants.

A maximum of thirty-two (32) participants will be enrolled overall, with a maximum of sixteen (16) participants enrolled into each part of the study.

There is to be a 28-day Screening period (Day -28 to -1) for both Part 1 and 2 of the study.

Both SAD and MAD will include four treatment cohorts (0.25%, 0.5%, 1% and 2%) of SOF-SKN.

Participants enrolled Part 1 (SAD) will receive a single dose of 2 g Soft-SKN cream while the participants enrolled in Part 2 (MAD) will receive daily applications of 2 g SOF-SKN cream for 14 days.

Inclusion criteria

• Healthy Volunteers 18 to 64 years.
• Participants with Fitzpatrick skin type I to IV.
• Participants must have a back surface area of at least 24 × 30 cm to accommodate two - 10 × 30 cm application areas with a 4 cm separation between them.
• No Allergies.
• Contraception.
• Must be willing to abstain from the use of moisturizers and other topical applications on the back 24 hours prior and for the duration of the study.

Exclusion criteria

• Allergic constitution.
• Within 72 hours of the start of study treatment, the use of antihistamines or use of topical drugs at the application site.
• Hair removing interventions including laser treatment, shaving and waxing in the target area within 1 week before Screening.
• Hypertrichosis on the back; no tattoos that cover greater than 30% of the back surface area.
• Presence of an inflammatory dermatosis (including, but not limited to, atopic dermatitis, eczema, psoriasis, extensive acne), and/or suntan/burn that could interfere with the test field evaluation.
• Non-inflammatory skin lesions and changes (including, but not limited to, hyperpigmentation, multiple naevi, tattoos, blemishes, birthmarks, abrasions, ulcers, eschar, and/or scabs) present in the target area on the back that could interfere with the test field evaluation.
• Any history of or presence of in situ melanoma and non-melanoma skin cancer within the last 3 years.
• Any other skin disease or other visible skin condition noted on physical examination which in the Investigator's opinion might interfere with the evaluation of the test field reaction.