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

Completed · Phase 1

Conditions studied: Celiac Disease, Healthy

In brief

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

Key facts

Study ID
NCT07063823
Run by
Nielsen Fernandez-Becker
People needed
18
Starts
2025-08-26
Expected to finish
2026-04-07
Last updated by the study team
2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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