A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease

Recruiting now · Phase 1

Conditions studied: Celiac Disease

In brief

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

Key facts

Study ID

NCT07377565

Run by

Nielsen Fernandez-Becker

People needed

20

Starts

2026-04-29

Expected to finish

2027-06-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University — Stanford, California, United States (enrolling)

Full record on ClinicalTrials.gov

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