Actively Recruiting
A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
Led by Nielsen Fernandez-Becker · Updated on 2026-04-20
20
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
N
Nielsen Fernandez-Becker
Lead Sponsor
S
Stanford's Innovative Medicines Accelerator
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Undergoing esophagogastroduodenoscopy (EGD) for suspected celiac disease
- Body Mass Index (BMI) between 18 and 45 kg/m2
- Creatinine less than 1.5 times the upper limit of normal (ULN)
- Total bilirubin less than or equal to 1.5 mg/dL times ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 1.5 times ULN
- Overall good health as determined by medical history and physical exam
- No use of investigational drugs within 12 weeks prior to the study
- Ability and willingness to follow study procedures and provide written informed consent
- If of childbearing potential, agreement to use highly effective birth control during the study; same requirement applies to male participants with partners of childbearing potential
You will not qualify if you...
- Pregnant, breastfeeding, planning to become pregnant, or intending to donate eggs during the study
- 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 those unable to consent for themselves
- Known HIV infection, positive hepatitis B or C test, or other 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Stanford Medicine Clinical and Translational Research Unit (CTRU)
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
J
Joaquin Tabera
CONTACT
M
Marissa Dobry
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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