First-in-patient safety test of HB-2121 for celiac disease diagnosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-patient, single-dose Phase 1 safety study of HB-2121 in adults undergoing esophagogastroduodenoscopy (EGD) for suspected celiac disease. Participants will take one oral dose of HB-2121 four hours before their routine EGD, and researchers will collect tissue and safety data during and after the procedure. Subjects will be followed for 30 days with four in-person visits, two remote safety visits, lab tests, and a short daily symptom questionnaire for seven days. The study focuses on tolerability, side effects, and how the agent interacts with the small intestine.

Why it matters

Who can join: the full rules

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

Where it's running

• Stanford University
  Stanford, California, United States Recruiting

Study contacts

• Study coordinator: Joaquin Tabera
• Email: jtabera7@stanford.edu
• Phone: (650) 334-1308

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.