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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 is a Phase 1 study that is actively recruiting participants, run by Nielsen Fernandez-Becker. The registered enrollment target is 20 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07377565
The ClinicalTrials.gov registry entry for NCT07377565 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nielsen Fernandez-Becker, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HB-2121 is the first listed.
NCT07377565 reports 0 study locations.
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.
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