[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635898":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":55,"studyPopulation":25,"armGroups":56,"interventions":71,"overallOfficials":77,"centralContacts":82,"locations":89,"responsibleParty":225,"collaborators":25,"id":227,"slug":25,"hasResults":228,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":25,"eligibilityCriteria":232,"healthyVolunteers":233,"sex":234,"minAge":235,"maxAge":236,"enrollmentInfo":237,"targetDuration":25,"studyType":240,"phases":241,"briefSummary":243,"conditions":244,"keywords":25,"overallStatus":92,"whyStopped":25,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},{"fullName":5,"class":6},"Sitryx Therapeutics Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"The Proportion of Participants With Treatment-Emergent Adverse Events","The number of participants who reported a treatment-emergent adverse event (TEAE) will be summarised.","Adverse events are collected from the date of consent until up to 10 days after the dose in Part 1 (Day 11), 14 days after the last dose in Part 2 (Day 28) and up to Day 56 in Part 3.",[14,18],{"measure":15,"description":16,"timeFrame":17},"Concentrations of SYX5219 in Plasma","Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for SYX-5219. This endpoint will report the summary of derived pharmacokinetic parameters for participants in all parts of the study.","For Part 1: 14 timepoints from pre-dose Day 1 up to 120 h post-dose Day 6. For Part 2: 28 timepoints from pre-dose Day 1 up to Day 19. For Part 3: 8 timepoints from pre-dose Day 1 up to Day 56.",{"measure":19,"description":20,"timeFrame":21},"Concentrations of SYX5219 in Urine","Urine samples were obtained in order to evaluate defined urine pharmacokinetic parameters for SYX-5219. This endpoint will report the summary of derived pharmacokinetic parameters for participants in Part 1 and Part 2 of the study.","For Part 1: continuous urine collection from Day 1 up to 48 hr post-dose on Day 2. For Part 2: continuous urine collection from Day 1 up to 48 hr post-dose on Day 2 and Day 14 up to 48 hr post-dose on Day 16.",[23,27,29,31,33,35,37,39,41,43],{"measure":24,"description":25,"timeFrame":26},"Percent change from baseline in the Eczema Area and Severity Index (EASI) - Part 3",null,"For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.",{"measure":28,"description":25,"timeFrame":26},"Proportion of participants achieving a 50% 75% and 90% reduction of EASI (EASI50 and EASI75 and EASI90) - Part 3",{"measure":30,"description":25,"timeFrame":26},"Proportion of participants achieving a minimum 2- grade improvement from baseline in validated Investigator Global Assessment (vIGA) score to clear (0) or almost clear (1) - Part 3",{"measure":32,"description":25,"timeFrame":26},"Percent change from baseline in peak pruritus numeric rating scale (PP-NRS) - Part 3",{"measure":34,"description":25,"timeFrame":26},"Proportion of participants with ≥3-point and ≥4-point improvement in peak pruritus numeric rating scale - Part 3",{"measure":36,"description":25,"timeFrame":26},"Percent change from baseline in weekly average of the daily PP-NRS scores - Part 3",{"measure":38,"description":25,"timeFrame":26},"Percent change from baseline in weekly average of the daily sleep loss scores - Part 3",{"measure":40,"description":25,"timeFrame":26},"Change from baseline and percent change from baseline in percent atopic dermatitis covering the body surface area (BSA) involvement - Part 3",{"measure":42,"description":25,"timeFrame":26},"Change from baseline in Dermatology Life Quality Index (DLQI) - Part 3",{"measure":44,"description":25,"timeFrame":26},"Change from baseline in Patient Orientated Eczema Measure (POEM) - Part 3",{"allocation":46,"interventionModel":47,"interventionModelDescription":25,"primaryPurpose":48,"observationalModel":25,"timePerspective":25,"maskingInfo":49},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":50,"maskingDescription":51,"whoMasked":52},"DOUBLE","Double-Blind",[53,54],"PARTICIPANT","INVESTIGATOR","This is a multi-part, adaptive, Phase 1, double-blind, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of SYX-5219 following single ascending doses (SAD), multiple ascending doses (MAD), and selected dosing in participants with atopic dermatitis (AD).\n\nParts 1 and 2 will be conducted at a single site in the UK. Part 3 will be conducted globally at multiple sites.\n\nPart 1 (Single Ascending Dose \\& Food Effect) Part 1 (SAD) will enrol up to 48 healthy participants in cohorts (3:1, active:placebo). Participants will receive single doses of SYX-5219, with a food effect evaluation including a second dosing period following washout.\n\nPart 2 (Multiple Ascending Dose) Part 2 (MAD) will enrol up to 24 healthy participants in cohorts (3:1, active:placebo). Participants will receive multiple doses of SYX-5219 over a defined treatment period.\n\nPart 3 (AD Participants) Part 3 will enrol up to 45 participants with AD across multiple global sites. Participants will be randomised (2:1) to receive SYX-5219 or placebo for up to 42 days. Prior exposure to targeted systemic therapy will be limited. Study assessments will include safety and exploratory efficacy evaluations during treatment and follow-up.",[57,63,67],{"label":58,"type":59,"description":60,"interventionNames":61},"Part 1 Single Ascending Dose (SAD)","EXPERIMENTAL","Single dose of SYX-5219 (active or matching placebo) administered on Day 1 for all cohorts and Day 1 of each treatment period for food effect cohorts (in fasted and fed conditions).",[62],"Drug: SYX-5219 Oral Capsule",{"label":64,"type":59,"description":65,"interventionNames":66},"Part 2 Multiple Ascending Dose (MAD)","Multiple doses of SYX-5219 (active or matching placebo) administered once or twice daily for all cohorts.",[62],{"label":68,"type":59,"description":69,"interventionNames":70},"Part 3 AD Participants Multiple Doses","Multiple doses of SYX-5219 (active or matching placebo) administered twice daily for multiple dose administration",[62],[72],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":25},"DRUG","SYX-5219 Oral Capsule","Oral Capsule to be administered at each specific dose level within each cohort",[58,64,68],[78],{"name":79,"affiliation":80,"role":81},"Sitryx Therapeutics","Study Sponsor","STUDY_DIRECTOR",[83,87],{"name":79,"role":84,"phone":85,"phoneExt":25,"email":86},"CONTACT","+44 (0)1865 648401","info@sitryx.com",{"name":79,"role":84,"phone":88,"phoneExt":25,"email":86},"+44 (0) 1865 648401",[90,104,113,122,131,140,149,159,170,180,188,197,207,217],{"facility":91,"status":92,"city":93,"state":94,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":25},"Sitryx Clinical Site","RECRUITING","Arkansas City","Arkansas","72117","United States","US",{"type":99,"coordinates":100},"Point",[101,102],-91.20678,33.60872,{"lat":102,"lon":101},{"facility":91,"status":92,"city":105,"state":106,"zip":107,"country":96,"countryCode":97,"cosmosGeoPoint":108,"geoPoint":112,"contacts":25},"Fremont","California","94538",{"type":99,"coordinates":109},[110,111],-121.98857,37.54827,{"lat":111,"lon":110},{"facility":91,"status":92,"city":114,"state":115,"zip":116,"country":96,"countryCode":97,"cosmosGeoPoint":117,"geoPoint":121,"contacts":25},"Plainfield","Indiana","46168",{"type":99,"coordinates":118},[119,120],-86.39944,39.70421,{"lat":120,"lon":119},{"facility":91,"status":92,"city":123,"state":124,"zip":125,"country":96,"countryCode":97,"cosmosGeoPoint":126,"geoPoint":130,"contacts":25},"Boardman","Ohio","44512",{"type":99,"coordinates":127},[128,129],-80.66285,41.02423,{"lat":129,"lon":128},{"facility":91,"status":92,"city":132,"state":133,"zip":134,"country":96,"countryCode":97,"cosmosGeoPoint":135,"geoPoint":139,"contacts":25},"Philadelphia","Pennsylvania","19103",{"type":99,"coordinates":136},[137,138],-75.16362,39.95238,{"lat":138,"lon":137},{"facility":91,"status":92,"city":141,"state":142,"zip":143,"country":96,"countryCode":97,"cosmosGeoPoint":144,"geoPoint":148,"contacts":25},"Bountiful","Utah","84010",{"type":99,"coordinates":145},[146,147],-111.88077,40.88939,{"lat":147,"lon":146},{"facility":91,"status":92,"city":150,"state":25,"zip":151,"country":152,"countryCode":153,"cosmosGeoPoint":154,"geoPoint":158,"contacts":25},"Sofia","1404","Bulgaria","BG",{"type":99,"coordinates":155},[156,157],23.32415,42.69751,{"lat":157,"lon":156},{"facility":91,"status":160,"city":161,"state":161,"zip":162,"country":163,"countryCode":164,"cosmosGeoPoint":165,"geoPoint":169,"contacts":25},"NOT_YET_RECRUITING","Herlev","2730","Denmark","DK",{"type":99,"coordinates":166},[167,168],12.43998,55.72366,{"lat":168,"lon":167},{"facility":91,"status":92,"city":171,"state":25,"zip":172,"country":173,"countryCode":174,"cosmosGeoPoint":175,"geoPoint":179,"contacts":25},"Berlin","10117","Germany","DE",{"type":99,"coordinates":176},[177,178],13.41053,52.52437,{"lat":178,"lon":177},{"facility":91,"status":92,"city":181,"state":25,"zip":182,"country":173,"countryCode":174,"cosmosGeoPoint":183,"geoPoint":187,"contacts":25},"Frankfurt","60596",{"type":99,"coordinates":184},[185,186],10.53333,49.68333,{"lat":186,"lon":185},{"facility":91,"status":189,"city":190,"state":25,"zip":191,"country":173,"countryCode":174,"cosmosGeoPoint":192,"geoPoint":196,"contacts":25},"ACTIVE_NOT_RECRUITING","Freiburg im Breisgau","79106",{"type":99,"coordinates":193},[194,195],7.85222,47.9959,{"lat":195,"lon":194},{"facility":91,"status":92,"city":198,"state":25,"zip":199,"country":200,"countryCode":201,"cosmosGeoPoint":202,"geoPoint":206,"contacts":25},"Dublin","D08 NHY1","Ireland","IE",{"type":99,"coordinates":203},[204,205],-6.24889,53.33306,{"lat":205,"lon":204},{"facility":91,"status":92,"city":208,"state":25,"zip":209,"country":210,"countryCode":211,"cosmosGeoPoint":212,"geoPoint":216,"contacts":25},"Manchester","M23 9QZ","United Kingdom","UK",{"type":99,"coordinates":213},[214,215],-2.23743,53.48095,{"lat":215,"lon":214},{"facility":91,"status":92,"city":218,"state":25,"zip":219,"country":210,"countryCode":211,"cosmosGeoPoint":220,"geoPoint":224,"contacts":25},"Merthyr Tydfil","CF48 4DR",{"type":99,"coordinates":221},[222,223],-3.37779,51.74794,{"lat":223,"lon":222},{"type":226,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":238,"type":239},149,"ESTIMATED","INTERVENTIONAL",[242],"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.",[245],"Moderate to Severe Atopic Dermatitis","2026-04-22",{"date":248,"type":249},"2026-04-30","ACTUAL",{"date":251,"type":249},"2025-02-26",{"date":253,"type":239},"2026-09-30",{"name":5,"class":6},14]