A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
Nielsen Fernandez-Becker
20 participants
Apr 1, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- 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 Criteria9
- 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
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Interventions
HB-2121 taken once orally.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07377565