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

RecruitingPhase 1Ages 18 Years - 65 YearsAllSitryx Therapeutics Ltd
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • SYX-5219 Oral Capsule
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Where

14 sites
Sitryx Clinical Site
Arkansas City, United States
Sitryx Clinical Site
Fremont, United States
Sitryx Clinical Site
Plainfield, United States
Sitryx Clinical Site
Boardman, United States
Sitryx Clinical Site
Philadelphia, United States
Sitryx Clinical Site
Bountiful, United States
Sitryx Clinical Site
Sofia, Bulgaria
Sitryx Clinical Site
Herlev, Denmark

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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