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

Recruiting now · Phase 1

Conditions studied: Moderate to Severe Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT07558668

Run by

Sitryx Therapeutics Ltd

People needed

149

Starts

2025-02-26

Expected to finish

2026-09-30

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Parts 1 \& 2
• Healthy male and female participant, between ≥ 18 to ≤ 65 years of age, inclusive, with a BMI of body mass index (BMI) of 18-32 kg/m2.
• Female participant of non-childbearing potential or female of childbearing potential that is sexually abstinent.
• No clinically significant abnormalities in laboratory, vital signs or ECG measurements.
• Part 3
• Male and female participants with clinically confirmed diagnosis of active AD, between ≥ 18 to ≤ 65 years of age, inclusive, with a BMI of body mass index (BMI) of ≤40 kg/m2.
• Meet minimum AD entry criteria;
• AD covering ≥10% of the body surface area (BSA) at screening and baseline.
• Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline.
• Validated Investigator's Global Assessment (vIGA) score of ≥ 3 (moderate) at screening and baseline.
• Peak Pruritus NRS score of ≥ 4 at screening and baseline.

You may not qualify if…

• Parts 1 \& 2
• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 35 days or 5 half-lives (whichever is longer) prior to the first dose of IMP.
• Part 3
• Any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the Investigator, put the participant at undue risk.
• Has medical history as stated in the main study exclusion criteria.
• Received treatment(s) as stated in the main study exclusion criteria.

Where it is running

• Sitryx Clinical Site — Arkansas City, Arkansas, United States (enrolling)
• Sitryx Clinical Site — Fremont, California, United States (enrolling)
• Sitryx Clinical Site — Plainfield, Indiana, United States (enrolling)
• Sitryx Clinical Site — Boardman, Ohio, United States (enrolling)
• Sitryx Clinical Site — Philadelphia, Pennsylvania, United States (enrolling)
• Sitryx Clinical Site — Bountiful, Utah, United States (enrolling)
• Sitryx Clinical Site — Sofia, Bulgaria (enrolling)
• Sitryx Clinical Site — Manchester, United Kingdom (enrolling)
• Sitryx Clinical Site — Merthyr Tydfil, United Kingdom (enrolling)
• Sitryx Clinical Site — Berlin, Germany (enrolling)
• Sitryx Clinical Site — Frankfurt, Germany (enrolling)
• Sitryx Clinical Site — Dublin, Ireland (enrolling)
• Sitryx Clinical Site — Herlev, Herlev, Denmark
• Sitryx Clinical Site — Freiburg im Breisgau, Germany

Full record on ClinicalTrials.gov

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