[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nielsen Fernandez-Becker\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100621972","phase-1-a-first-in-patient-study-to-evaluate-the-safety-and-tolerability-of-hb-2121-as-a-diagnostic-for-celiac-disease-100621972",false,"NCT07377565","A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease","Inclusion Criteria:\n\n* Age 18 to 75 years\n* Undergoing esophagogastroduodenoscopy (EGD) for suspected celiac disease\n* Body Mass Index (BMI) between 18 and 45 kg\u002Fm2\n* Creatinine \\\u003C 1.5 x Upper Limit of the Normal (ULN)\n* Total bilirubin ≤ 1.5 mg\u002FdL x (ULN)\n* Aspartate aminotransferase (AST)\u002FSerum glutamic oxaloacetic transaminase (SGOT) \\& Alanine Aminotransferase (ALT)\u002FSerum glutamic pyruvic transaminase (SGPT) ≤ 1.5 x ULN\n* Overall good health, as determined by medical history and a physical exam\n* No use of an investigational drug within 12 weeks\n* Able and willing to follow study procedures and provide written informed consent\n* If of childbearing potential, participants must agree to use highly effective birth control during the study period. The same applies to male participants with partners of childbearing potential\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, planning to become pregnant, or intending to donate eggs during the study period\n* History of cancer or malignancy\n* History of chemotherapy and\u002For pelvic radiation\n* History of congenital long QT syndrome or prolonged QTcF interval\n* Prisoners, institutionalized individuals, or individuals who are unable to consent for themselves\n* Known HIV infection, or positive test for hepatitis B or C, or other clinically significant chronic liver disease\n* Current use of immunosuppressant medications\n* Known allergy or sensitivity to any ingredients in the study drug\n* History of eosinophilic enteritis, Crohn's disease, or ulcerative colitis","ALL","18 Years",{"count":18,"type":19},20,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","The goal of this clinical trial is to learn about the safety of a single dose of HB-2121 in adults with suspected celiac disease. It will also look at how the drug affects the small intestine. The main questions it aims to answer are:\n\n* What side effects do participants have after receiving HB-2121?\n* How does the drug interact with the small intestine in people with suspected celiac disease?\n\nResearchers will follow participants for 30 days after receiving HB-2121 to understand how the drug behaves in the body and how safe it is.\n\nParticipants will:\n\n* Receive one oral dose of HB-2121 four hours before their standard-of-care esophagogastroduodenoscopy\n* Attend 4 in-person clinic visits for checkups, lab tests, and monitoring\n* Complete 2 remote visits that include safety lab assessments\n* Fill out a short daily questionnaire for 7 days about symptoms and health status",[25],"Celiac Disease",[25,27,28,29],"HB-2121","Gluten Intolerance","Esophagogastroduodenoscopy","RECRUITING","2026-06-26",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":34},"2026-04-29",{"date":38,"type":19},"2027-06-01",{"name":40,"class":41},"Nielsen Fernandez-Becker","OTHER",""]