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| Name | Class |
|---|---|
| Stanford's Innovative Medicines Accelerator | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 250 mg HB-2121 in Participants with Suspected Celiac Disease | Experimental | Participants in this arm will receive a one-time dose of 250 mg of HB-2121. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HB-2121 | Drug | HB-2121 taken once orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From dosing through 30 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 240 minutes after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-dose, 60 minutes after dosing, and 360 minutes after dosing |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joaquin Tabera | Contact | (650) 334-1308 | jtabera7@stanford.edu | |
| Marissa Dobry | Contact | (313) 320-2240 | mdobry@stanford.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 28, 2026 | Jun 12, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 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. | 240 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. | 240 minutes after dosing |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |