A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
A legfontosabb adatok
- Hol
- Stanford (Egyesült Államok)A helyszín megnézése
- Fázis
- 1. fázis
Helyszínek itt: Egyesült Államok
- Stanford UniversityStanford, Egyesült ÁllamokContact: Joaquin TaberaRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Nielsen Fernandez-Becker
- Azonosító
- NCT07377565
- A regiszteradat frissítve
- 2026. július 28.
- Eredeti leírás
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:A teljes eredeti leírásKevesebb
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:
* What side effects do participants have after receiving HB-2121? * How does the drug interact with the small intestine in people with suspected celiac disease?
Researchers will follow participants for 30 days after receiving HB-2121 to understand how the drug behaves in the body and how safe it is.
Participants will:
* Receive one oral dose of HB-2121 four hours before their standard-of-care esophagogastroduodenoscopy * Attend 4 in-person clinic visits for checkups, lab tests, and monitoring * Complete 2 remote visits that include safety lab assessments * Fill out a short daily questionnaire for 7 days about symptoms and health status
Bevonási feltételek: Age 18 to 75 years; Undergoing esophagogastroduodenoscopy (EGD) for suspected celiac disease; Body Mass Index (BMI) between 18 and 45 kg/m2; Creatinine < 1.5 x Upper Limit of the Normal (ULN); Total bilirubin ≤ 1.5 mg/dL x (ULN); Aspartate aminotransferase (AST)/Serum glutamic oxaloacetic transaminase (SGOT) \& Alanine Aminotransferase (ALT)/Serum glutamic pyruvic transaminase (SGPT) ≤ 1.5 x ULN; Overall good health, as determined by medical history and a physical exam; No use of an investigational drug within 12 weeks; Able and willing to follow study procedures and provide written informed consent; 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.
Kizáró feltételek: Current use of immunosuppressant medications; History of cancer or malignancy; History of chemotherapy and/or pelvic radiation; Known HIV infection, or positive test for hepatitis B or C, or other clinically significant chronic liver disease; Known allergy or sensitivity to any ingredients in the study drug; History of eosinophilic enteritis, Crohn's disease, or ulcerative colitis; History of congenital long QT syndrome or prolonged QTcF interval; Pregnant, breastfeeding, planning to become pregnant, or intending to donate eggs during the study period; Prisoners, institutionalized individuals, or individuals who are unable to consent for themselves.