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NCT07377565 · ClinicalTrials.gov registry record · Phase 1
A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
A Phase 1 study, sponsored by Nielsen Fernandez-Becker.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT07377565: Recruiting Phase 1 study, sponsored by Nielsen Fernandez-Becker.
NCT07377565 is a Phase 1 study that is actively recruiting participants, run by Nielsen Fernandez-Becker. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07377565, a Phase 1 study, is actively recruiting participants, sponsored by Nielsen Fernandez-Becker.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn about the safety of a single dose of HB-2121 in adults with suspected celiac disease. It will also look at how the drug affects the small intestine. The main questions it aims to answer are: * What side effects do participants have after receiving HB-2121? * How does the drug interact with the small intestine in people with suspected celiac disease? 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 four hours before their standard-of-care esophagogastroduodenoscopy * 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
Primary Outcome
Adverse events (AEs) will be recorded and assessed for severity using the Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Interventions
- DRUG HB-2121
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-04-29 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 1 |
What NCT07377565 shows while recruiting
NCT07377565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which HB-2121 is the first listed.
NCT07377565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07377565 about?
NCT07377565 is a clinical study titled "A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease". The goal of this clinical trial is to learn about the safety of a single dose of HB-2121 in adults with suspected celiac disease. It will also look at how the drug affects the small intestine. The main questions it aims to answer are: * What side effects do participants have after receiving HB-2121...
What is the current status of trial NCT07377565?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2026-04-29. Estimated completion is 2027-06-01.
What interventions are being tested in trial NCT07377565?
The interventions under investigation include: HB-2121 (DRUG).
Who is sponsoring clinical trial NCT07377565?
This trial is sponsored by Nielsen Fernandez-Becker, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07377565's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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