Clinical Trial

A First-in-human Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease

Completed Phase 1
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn about the safety of a single dose of HB-2121 in adults. It will also look at how the body processes the drug. The main questions it aims to answer are: * What side effects do participants have after receiving HB-2121? * How much HB-2121 is in the blood over time? 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 * 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
Protocol Amendment History 1 change
critical Trial completed 2026-04-21
Trial Details
NCT Number NCT07063823
Lead Sponsor Nielsen Fernandez-Becker
Collaborators: Stanford's Innovative Medicines Accelerator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Celiac Disease, Healthy
Enrollment 18 participants
Start Date 2025-08-26
Primary Completion 2026-04-07 (estimated)
Study Completion 2026-04-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-28