A First-in-human Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
Status:
RECRUITING
Trial end date:
2026-02-07
Target enrollment:
Participant gender:
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