A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis
Recruiting · NCT07558668 · Interventional (participants receive a specific treatment) · Lead sponsor: Sitryx Therapeutics Ltd
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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
14 locations listed across 6 US states.
- 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 - Berlin, Germany
- Sitryx Clinical Site - Dublin, Ireland
- Sitryx Clinical Site - Frankfurt, Germany
- Sitryx Clinical Site - Freiburg im Breisgau, Germany
- Sitryx Clinical Site - Manchester, United Kingdom
- Sitryx Clinical Site - Merthyr Tydfil, United Kingdom
- Sitryx Clinical Site - Sofia, Bulgaria
- Sitryx Clinical Site - Herlev, Herlev, Denmark