Summary
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
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Prisoners, institutionalized individuals, or individuals who are unable to consent for themselves
* Known HIV infection, or positive test for hepatitis B or C, or other clinically significant chronic liver disease
* Current use of immunosuppressant medications
* Known allergy or sensitivity to any ingredients in the study drug
* History of eosinophilic enteritis, Crohn's disease, or ulcerative colitis