Clinical Trial

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

Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
The purpose of this study is to evaluate the study drug, SYX-5219, in a multi-part First-in-Human (FiH) study to be conducted in healthy volunteers and participants with Atopic Dermatitis (AD). The objectives of this study are to determine the safety, tolerability and levels of SYX-5219 in the blood and urine when SYX-5219 is given in each part of the study (SAD, MAD, Food Effect and Participants with AD). The study will be split into up to 3 parts as follows: * Part 1 - Single Ascending Dose (SAD) and Food Effect in healthy volunteers * Part 2 - Multiple Ascending Dose (MAD) in healthy volunteers * Part 3 - Multiple Dose in Participants with AD - enrolling up to 45 males and females with a confirmed diagnosis of AD of at least 6 months, evaluating multiple dose administrations of SYX-5219 or placebo daily over a period of 42 days.
Trial Details
NCT Number NCT07558668
Lead Sponsor Sitryx Therapeutics Ltd
Conditions Moderate to Severe Atopic Dermatitis
Enrollment 149 participants
Start Date 2025-02-26
Primary Completion 2026-08-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-30