Celiac Disease
Conditions
Keywords
Celiac Disease, HB-2121, Gluten Intolerance, Esophagogastroduodenoscopy
Brief 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
Interventions
DRUGHB-2121
HB-2121 taken once orally.
Sponsors
Nielsen Fernandez-Becker
Stanford's Innovative Medicines Accelerator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and severity of adverse events during the study window | From dosing through 30 days post-dose | Adverse events (AEs) will be recorded and assessed for severity using the Common Terminology Criteria for Adverse Events (CTCAE) v6.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of sulfo-Cy5 fluorescent marker normalized to the mean fluorescence intensity of DAPI-stained nuclei in a confocal fluorescent microscopic field of view. | At least 120 minutes after dosing | Endoscopic biopsy samples will be collected after dosing, and fresh frozen tissue sections will be stained with DAPI and analyzed using a confocal microscope to determine the fluorescence intensity of sulfo-Cy5 and DAPI. |
| Measurement of villous height to crypt depth ratio and intraepithelial lymphocyte count. | At least 120 minutes after dosing | Endoscopic biopsy samples will be collected after dosing, and the paraffin-embedded tissue sections will be stained with hematoxylin and eosin, as well as CD3, and analyzed using a microscope to determine villus height, crypt depth, and the number of CD3+ intraepithelial lymphocytes. |
Countries
United States
Contacts
CONTACTJoaquin Tabera
CONTACTMarissa Dobry
Outcome results
None listed