A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis
Eligible age
18–65 yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
Yes
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About this study
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.
Sponsor: Sitryx Therapeutics Ltd
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.
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's recruiting
Arkansas City
Fremont
Plainfield
Boardman
Philadelphia
Bountiful
Source: ClinicalTrials.gov · NCT07558668 · last updated 2026-04-30