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A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis
Sponsor: Sitryx Therapeutics Ltd
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.
Official title: A Multi-part, FiH Study in Healthy Participants and Participants With Atopic Dermatitis (AD) to Assess the Safety, Tolerability, Pharmacokinetics (PK) of Single & Multiple Ascending Doses and Selected Dose of SYX-5219 (AD Participants).
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
149
Start Date
2025-02-26
Completion Date
2026-09-30
Last Updated
2026-04-30
Healthy Volunteers
Yes
Conditions
Interventions
SYX-5219 Oral Capsule
Oral Capsule to be administered at each specific dose level within each cohort
Locations (14)
Sitryx Clinical Site
Arkansas City, Arkansas, United States
Sitryx Clinical Site
Fremont, California, United States
Sitryx Clinical Site
Plainfield, Indiana, United States
Sitryx Clinical Site
Boardman, Ohio, United States
Sitryx Clinical Site
Philadelphia, Pennsylvania, United States
Sitryx Clinical Site
Bountiful, Utah, United States
Sitryx Clinical Site
Sofia, Bulgaria
Sitryx Clinical Site
Herlev, Herlev, Denmark
Sitryx Clinical Site
Berlin, Germany
Sitryx Clinical Site
Frankfurt, Germany
Sitryx Clinical Site
Freiburg im Breisgau, Germany
Sitryx Clinical Site
Dublin, Ireland
Sitryx Clinical Site
Manchester, United Kingdom
Sitryx Clinical Site
Merthyr Tydfil, United Kingdom