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
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)
Pregnant, breastfeeding, planning to become pregnant, or intending to donate eggs during the study period
History of cancer or malignancy
History of chemotherapy and/or pelvic radiation
History of congenital long QT syndrome or prolonged QTcF interval
Nielsen Fernandez-Becker
Lead sponsor
Stanford University
Sponsor institution
Stanford's Innovative Medicines Accelerator
Collaborator