Phase 1 Study of SYX-5219 in Healthy Adults and Adults with Moderate to Severe Atopic Dermatitis Evaluating Safety, Tolerability, and Drug Levels After Single and Multiple Doses

What this Trial Is About

Researchers are evaluating SYX-5219 in a multi-part, first-in-human Phase 1 study involving healthy volunteers and people with moderate to severe atopic dermatitis AD. The study aims to determine the safety, tolerability, and levels of SYX-5219 in blood and urine when given in different dosing schedules. This includes single ascending doses, multiple ascending doses, and multiple dose administrations in participants with AD. The study has three parts Part 1 involves single ascending doses and a food effect evaluation in healthy volunteers, with doses given once on Day 1 and again after a washout period. Part 2 involves multiple ascending doses given once or twice daily to healthy volunteers over a defined period. Part 3 enrolls participants with AD who receive SYX-5219 or placebo twice daily for up to 42 days. Each part includes randomization and placebo control to compare effects. Participants will undergo safety and exploratory efficacy assessments during and after treatment, including monitoring adverse events up to 10 days after dosing in Part 1, 14 days after the last dose in Part 2, and up to Day 56 in Part 3. Blood and urine samples are collected at multiple timepoints to measure SYX-5219 levels. The study includes follow-up visits to monitor participant health and drug effects for several weeks after treatment ends.

A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis