[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621972":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":45,"collaborators":49,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":55,"sex":59,"minAge":60,"maxAge":20,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Stanford University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"250 mg HB-2121 in Participants with Suspected Celiac Disease","EXPERIMENTAL","Participants in this arm will receive a one-time dose of 250 mg of HB-2121.",[13],"Drug: HB-2121",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","HB-2121","HB-2121 taken once orally.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Joaquin Tabera","CONTACT","(650) 334-1308","jtabera7@stanford.edu",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Marissa Dobry","(313) 320-2240","mdobry@stanford.edu",[32],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":20},"RECRUITING","Stanford","California","94305","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-122.16608,37.42411,{"lat":43,"lon":42},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Nielsen Fernandez-Becker","Clinical Professor, Medicine - Gastroenterology & Hepatology",[50],{"name":51,"class":52},"Stanford's Innovative Medicines Accelerator","UNKNOWN","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":62,"type":63},20,"ESTIMATED","INTERVENTIONAL",[66],"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",[69],"Celiac Disease",[69,17,71,72],"Gluten Intolerance","Esophagogastroduodenoscopy","2026-06-26",{"date":75,"type":76},"2026-06-30","ACTUAL",{"date":78,"type":76},"2026-04-29",{"date":80,"type":63},"2027-06-01",{"name":47,"class":6},1]