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
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)
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
Single group
HB-2121
DrugHB-2121 taken once orally.
Frequency and severity of adverse events during the study window
Adverse events (AEs) will be recorded and assessed for severity using the Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Intensity of sulfo-Cy5 fluorescent marker normalized to the mean fluorescence intensity of DAPI-stained nuclei in a confocal fluorescent microscopic field of view.
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.
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.
Frequency and identity of HB-2121 positive cells in the blood of celiac patients
Blood samples will be collected at the end of the overall endoscopic evaluation procedure, and peripheral blood mononuclear cells (PBMCs) will be analyzed using flow cytometry to determine the percentage of HB-2121+ cells among CD14+CD11c+ populations, with and without β7-integrin expression.
Intensity of of HB-2121-labeled ECM-associated and cellular TG2 protein in duodenal biopsy samples.
Endoscopic biopsy samples will be collected after dosing, and the paraffin-embedded tissue sections will be stained with Collagen 1, PDGFRα, αSMA, CD11c, as well as DAPI, and analyzed using the confocal microscope to determine HB-2121 colocalization with ECM proteins and cell populations.
Click on the lead sponsor to view all of their trials.
Nielsen Fernandez-Becker
Lead sponsor
Stanford University
Sponsor institution
Stanford's Innovative Medicines Accelerator
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
