A Phase 1 interventional study of HB-2121 in Celiac Disease, sponsored by Nielsen Fernandez-Becker. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Nielsen Fernandez-Becker · Phase 1, Interventional, and Diagnostic
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:
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:
333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 203 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →Nielsen Fernandez-Becker is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this arm will receive a one-time dose of 250 mg of HB-2121.
Drug: HB-2121
HB-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.
Time frame: From dosing through 30 days post-dose
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.
Time frame: At least 120 minutes after dosing
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.
Time frame: At least 120 minutes after dosing
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.
Time frame: Pre-dose, 60 minutes after dosing, and 360 minutes after dosing
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.
Time frame: At least 120 minutes after dosing
Documents are hosted by the registry — open the source record to download them.
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Nielsen Fernandez-Becker