NCT07063823

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Nielsen Fernandez-Becker · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Celiac Disease
• Healthy

Interventions

Type	Name	Description
DRUG	HB-2121	HB-2121 taken once orally.

Timeline

• Start date: 2025-08-26
• Primary completion: 2026-04-15
• Completion: 2026-04-15
• First posted: 2025-07-14
• Last updated: 2026-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study