[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Barinthus Biotherapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Celiac Disease","RECRUITING","2026-06-17",{"date":31,"type":32},"2026-06-18","ACTUAL",{"date":34,"type":32},"2024-08-01",{"date":36,"type":21},"2026-11",{"name":38,"class":39},"Barinthus Biotherapeutics","INDUSTRY",16,""]