[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539934":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":44,"centralContacts":44,"locations":50,"responsibleParty":291,"collaborators":44,"id":293,"slug":294,"hasResults":295,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":44,"eligibilityCriteria":299,"healthyVolunteers":295,"sex":300,"minAge":301,"maxAge":302,"enrollmentInfo":303,"targetDuration":44,"studyType":306,"phases":307,"briefSummary":309,"conditions":310,"keywords":44,"overallStatus":53,"whyStopped":44,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":321},{"fullName":5,"class":6},"Barinthus Biotherapeutics","INDUSTRY",[8,14,20,23,26,29,32,35],{"label":9,"type":10,"description":11,"interventionNames":12},"Matched Placebo (SAD)","PLACEBO_COMPARATOR","2 placebo comparators; 1 for each part of the study",[13],"Other: Matched Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"VTP-1000 Dose 1 (SAD)","EXPERIMENTAL","3 dose levels in SAD and MAD parts of trial",[19],"Biological: VTP-1000",{"label":21,"type":16,"description":17,"interventionNames":22},"VTP-1000 Dose 2 (SAD)",[19],{"label":24,"type":16,"description":17,"interventionNames":25},"VTP-1000 Dose 3 (SAD)",[19],{"label":27,"type":10,"description":11,"interventionNames":28},"Matched Placebo (MAD)",[13],{"label":30,"type":16,"description":17,"interventionNames":31},"VTP-1000 Dose 1 (MAD)",[19],{"label":33,"type":16,"description":17,"interventionNames":34},"VTP-1000 Dose 2 (MAD)",[19],{"label":36,"type":16,"description":17,"interventionNames":37},"VTP-1000 Dose 3 (MAD)",[19],[39,45],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"BIOLOGICAL","VTP-1000","Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component",[30,15,33,21,36,24],null,{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":44},"OTHER","Matched Placebo","Intramuscular (IM) injection comprised of saline solution",[27,9],[51,71,86,101,115,128,143,157,172,186,201,216,231,246,261,276],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Parexel EPCU LA","RECRUITING","Los Angeles","California","91206","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-118.24368,34.05223,{"lat":63,"lon":62},[66],{"name":67,"role":68,"phone":69,"phoneExt":44,"email":70},"Jess Mehrasaz","CONTACT","626-298-2756","jess.mehrsaz@parexel.com",{"facility":72,"status":53,"city":73,"state":74,"zip":75,"country":57,"countryCode":58,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Peak Gastroenterology Associates","Colorado Springs","Colorado","80907",{"type":60,"coordinates":77},[78,79],-104.82136,38.83388,{"lat":79,"lon":78},[82],{"name":83,"role":68,"phone":84,"phoneExt":44,"email":85},"Rutva Nakarani","719-636-1201","rnakarani@peakgastro.com",{"facility":87,"status":53,"city":88,"state":89,"zip":90,"country":57,"countryCode":58,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Jacksonville Center for Clinical Research","Jacksonville","Florida","32216",{"type":60,"coordinates":92},[93,94],-81.65565,30.33218,{"lat":94,"lon":93},[97],{"name":98,"role":68,"phone":99,"phoneExt":44,"email":100},"Sara Villotti","904-730-0101","svillotti@encoredocs.com",{"facility":102,"status":53,"city":103,"state":89,"zip":104,"country":57,"countryCode":58,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"GCP Research","St. Petersburg","33705",{"type":60,"coordinates":106},[107,108],-82.67927,27.77086,{"lat":108,"lon":107},[111],{"name":112,"role":68,"phone":113,"phoneExt":44,"email":114},"Jessica Cruz","727-520-1427","jcruz@researchgcp.com",{"facility":116,"status":53,"city":117,"state":118,"zip":119,"country":57,"countryCode":58,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Parexel EPCU Baltimore","Baltimore","Maryland","21225",{"type":60,"coordinates":121},[122,123],-76.61219,39.29038,{"lat":123,"lon":122},[126],{"name":127,"role":68,"phone":69,"phoneExt":44,"email":70},"Jess Mehrsaz",{"facility":129,"status":53,"city":130,"state":131,"zip":132,"country":57,"countryCode":58,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Clinical Research Institute of Michigan","Clinton Township","Michigan","48038",{"type":60,"coordinates":134},[135,136],-82.91992,42.58698,{"lat":136,"lon":135},[139],{"name":140,"role":68,"phone":141,"phoneExt":44,"email":142},"Molly Wythe","586-598-3329","mwythe@researchmi.com",{"facility":144,"status":53,"city":145,"state":131,"zip":146,"country":57,"countryCode":58,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"West Michigan Clinical Research Center","Wyoming","49159",{"type":60,"coordinates":148},[149,150],-85.70531,42.91336,{"lat":150,"lon":149},[153],{"name":154,"role":68,"phone":155,"phoneExt":44,"email":156},"Rochelle Copeland","616-328-5344","rcopeland@gastro-assoc-wm.com",{"facility":158,"status":53,"city":159,"state":160,"zip":161,"country":57,"countryCode":58,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Mayo Clinic","Rochester","Minnesota","55905",{"type":60,"coordinates":163},[164,165],-92.4699,44.02163,{"lat":165,"lon":164},[168],{"name":169,"role":68,"phone":170,"phoneExt":44,"email":171},"Chadrick Hinson","507-266-0237","Hinson.chadrick@mayo.edu",{"facility":173,"status":53,"city":174,"state":174,"zip":175,"country":57,"countryCode":58,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"NYU Langone - Gastroenterology Associates","New York","10016",{"type":60,"coordinates":177},[178,179],-74.00597,40.71427,{"lat":179,"lon":178},[182],{"name":183,"role":68,"phone":184,"phoneExt":44,"email":185},"Valeria Pasuizaca-Yanez","212-263-3095","Valeria.Pasuizaca-Yanez@nyulangone.org",{"facility":187,"status":53,"city":188,"state":189,"zip":190,"country":57,"countryCode":58,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"North Carolina Clinical Research","Raleigh","North Carolina","27607",{"type":60,"coordinates":192},[193,194],-78.63861,35.7721,{"lat":194,"lon":193},[197],{"name":198,"role":68,"phone":199,"phoneExt":44,"email":200},"Daunita Audesuyi","919-881-0309","dadesuyi@nccr.com",{"facility":202,"status":53,"city":203,"state":204,"zip":205,"country":57,"countryCode":58,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Centricity Research","Columbus","Ohio","43213",{"type":60,"coordinates":207},[208,209],-82.99879,39.96118,{"lat":209,"lon":208},[212],{"name":213,"role":68,"phone":214,"phoneExt":44,"email":215},"Stephanie Scarberry","614-501-6164","Stephanie.Scarberry@centricityresearch.com",{"facility":217,"status":53,"city":218,"state":219,"zip":220,"country":57,"countryCode":58,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":60,"coordinates":222},[223,224],-86.78444,36.16589,{"lat":224,"lon":223},[227],{"name":228,"role":68,"phone":229,"phoneExt":44,"email":230},"Mary Vozar","615-936-1288","mary.c.vozar@vumc.org",{"facility":232,"status":53,"city":233,"state":234,"zip":235,"country":57,"countryCode":58,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"PPD Research Unit","Austin","Texas","78744",{"type":60,"coordinates":237},[238,239],-97.74306,30.26715,{"lat":239,"lon":238},[242],{"name":243,"role":68,"phone":244,"phoneExt":44,"email":245},"Al Gonzalez","512-747-4656","Al.Gonzalez@ppd.com",{"facility":247,"status":53,"city":248,"state":249,"zip":250,"country":57,"countryCode":58,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Velocity Clinical Research, Salt Lake City","West Jordan","Utah","84088",{"type":60,"coordinates":252},[253,254],-111.9391,40.60967,{"lat":254,"lon":253},[257],{"name":258,"role":68,"phone":259,"phoneExt":44,"email":260},"Srinivas Mulamalla","801-542-8190","smulamalla@velocityclinical.com",{"facility":262,"status":53,"city":263,"state":264,"zip":265,"country":57,"countryCode":58,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"Clinical Research Partners","Richmond","Virginia","23226",{"type":60,"coordinates":267},[268,269],-77.46026,37.55376,{"lat":269,"lon":268},[272],{"name":273,"role":68,"phone":274,"phoneExt":44,"email":275},"Aundraya Bray","804-477-3045","at@clinicalresearchrva.com",{"facility":277,"status":53,"city":278,"state":279,"zip":280,"country":57,"countryCode":58,"cosmosGeoPoint":281,"geoPoint":285,"contacts":286},"Velocity Clinical Research, Seattle","Seattle","Washington","98105",{"type":60,"coordinates":282},[283,284],-122.33207,47.60621,{"lat":284,"lon":283},[287],{"name":288,"role":68,"phone":289,"phoneExt":44,"email":290},"Luis Casanova","206-710-1574","lcasanova@velocityclinical.com",{"type":292,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100539934","early-phase-1-vtp-1000-in-adults-with-celiac-disease-100539934",false,"NCT06310291","VTP-1000 in Adults With Celiac Disease","A Phase 1, First in Human, Randomized, Placebo-controlled Trial With a Controlled Gluten Challenge to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VTP-1000 in Adults With Celiac Disease","Inclusion Criteria:\n\n* Diagnosis of celiac disease as confirmed by positive serology and intestinal histology\n* Presence of Human Leukocyte Antigen (HLA)-DQ2.5 genotype\n* Participants who are on a well controlled gluten restricted diet\n* Anti-tissue transglutaminase (tTG) IgA antibodies less than 2 times the upper limit of normal and anti-deamidated gliadin peptide IgG (anti-DGP)-IgA\u002FIgA antibodies less than 3 times the upper limit of normal\n* Non-pregnant or breast feeding females\n* No other clinical significant findings at screening\n\nExclusion Criteria:\n\n* Refractory celiac disease\n* Selective IgA deficiency\n* Positive for HLA-DQ8\n* Known wheat allergy or that is Type I hypersensitivity\n* Active inflammatory bowel disease or other condition with symptoms that will be similar to celiac disease","ALL","18 Years","70 Years",{"count":304,"type":305},45,"ESTIMATED","INTERVENTIONAL",[308],"EARLY_PHASE1","GLU001 is a first-in-human clinical trial to assess the safety and tolerability of VTP-1000 for adults with celiac disease. This trial will assess VTP-1000 at various dose levels compared to placebo in a single ascending dose (SAD) and multiple ascending dose (MAD) format. Participants will be followed for a short period of time to assess the impact of VTP-1000 on their immune system (Adverse events, reactions in the blood, and physical exam differences). Participants enrolled in the MAD portion of the trial will undergo a gluten challenge to assess the impact exposure to gluten has on participants after administration of VTP-1000.",[311],"Celiac Disease","2026-06-17",{"date":314,"type":315},"2026-06-18","ACTUAL",{"date":317,"type":315},"2024-08-01",{"date":319,"type":305},"2026-11",{"name":5,"class":6},16]