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4DR",{"type":51,"coordinates":173},[174,175],-3.37779,51.74794,{"lat":175,"lon":174},{"type":178,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100635898","phase-1-a-3-part-study-of-syx-5219-in-healthy-volunteers-and-participants-with-atopic-dermatitis-100635898",false,"NCT07558668","A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis","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).","Inclusion Criteria:\n\nParts 1 \\& 2\n\n* 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\u002Fm2.\n* Female participant of non-childbearing potential or female of childbearing potential that is sexually abstinent.\n* No clinically significant abnormalities in laboratory, vital signs or ECG measurements.\n\nPart 3\n\n* 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\u002Fm2.\n* Meet minimum AD entry criteria;\n\n  * AD covering ≥10% of the body surface area (BSA) at screening and baseline.\n  * Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline.\n  * Validated Investigator's Global Assessment (vIGA) score of ≥ 3 (moderate) at screening and baseline.\n  * Peak Pruritus NRS score of ≥ 4 at screening and baseline.\n\nExclusion Criteria:\n\nParts 1 \\& 2\n\n• 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.\n\nPart 3\n\n* Any clinically significant medical condition or physical\u002Flaboratory\u002FECG\u002Fvital signs abnormality that would, in the opinion of the Investigator, put the participant at undue risk.\n* Has medical history as stated in the main study exclusion criteria.\n* Received treatment(s) as stated in the main study exclusion criteria.",true,"ALL","18 Years","65 Years",{"count":191,"type":192},149,"ESTIMATED","INTERVENTIONAL",[195],"PHASE1","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).\n\nThe study will be split into up to 3 parts as follows:\n\n* Part 1 - Single Ascending Dose (SAD) and Food Effect in healthy volunteers\n* Part 2 - Multiple Ascending Dose (MAD) in healthy volunteers\n* 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.",[198],"Moderate to Severe Atopic Dermatitis","2026-04-22",{"date":201,"type":202},"2026-04-30","ACTUAL",{"date":204,"type":202},"2025-02-26",{"date":206,"type":192},"2026-09-30",{"name":5,"class":6},14]