Phase I Study to Assess Safety and How the Body Processes SOF-SKN Topical Cream in Healthy Adults Aged 18 to 64

What this Trial Is About

Researchers are evaluating the safety and tolerability of SOF-SKN cream applied topically in healthy volunteers aged 18 to 64 years. The study is designed in two parts Part 1 uses a single ascending dose SAD approach, and Part 2 uses a multiple ascending dose MAD approach. This phase I clinical trial aims to monitor how the body reacts to different concentrations of the cream and to assess pharmacokinetics. The study includes four dose levels 0.25%, 0.5%, 1%, and 2% applied as 2 g of SOF-SKN cream to a 10 x 30 cm area on either side of the participants back. Part 1 participants receive a single application, while Part 2 participants apply the cream daily for 14 days. Each participant also receives a placebo cream on the opposite side of the back to serve as a control. Safety monitoring will be conducted throughout the dose escalation. Participants will undergo a 28-day screening before dosing. After treatment, safety assessments will be made by tracking target toxicities, adverse events, and serious adverse events over days following the last application. Pharmacokinetic measurements will be taken at multiple timepoints up to 24 hours after a single dose and up to 17 days for multiple doses. The study will enroll up to 32 participants, with up to 16 in each part, and will follow them closely to monitor safety and how the drug behaves in the body.

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