Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants
brief 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.
detailed description
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.
official title
A Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of SOF-SKN in Healthy Participants