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Phase 1 Study to Assess Safety and Tolerability of a Single Oral Dose of HB-2121 for Diagnosing Celiac Disease in Adults
Led by Nielsen Fernandez-Becker · Updated on 2026-07-28
20
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of a single oral dose of HB-2121 in adults suspected of having celiac disease. This phase 1 clinical trial aims to understand any side effects after taking HB-2121 and how the drug interacts with the small intestine. The study focuses on adult participants undergoing standard diagnostic procedures for suspected celiac disease. Participants will receive a one-time oral dose of 250 mg HB-2121 four hours before their scheduled esophagogastroduodenoscopy EGD. The study includes a total of six visits four in-person clinic visits for health checkups, lab tests, and monitoring, as well as two remote visits involving safety lab assessments. Participants will also complete a daily questionnaire for seven days to report symptoms and health status. Throughout the study, researchers will monitor participants for 30 days post-dose to observe the frequency and severity of any adverse events. They will assess how the drug affects the small intestine by measuring specific markers such as fluorescence intensity and tissue characteristics from biopsy samples taken during the EGD. Safety labs, physical exams, and symptom questionnaires will be used to track participant health and drug effects during the trial period.
CONDITIONS
Brief Title
A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
Research Team
J
Joaquin Tabera
M
Marissa Dobry
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