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

Summary

The goal of this study is to investigate the safety and tolerability of the topical application of SOF-SKN in healthy volunteers. The study will be divided into part 1 and part 2. Part 1, is a single ascending dose (SAD) design, while Part 2 is a multiple ascending dose (MAD) design.

Eligibility

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.

Conditions2

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