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NCT07063823 · ClinicalTrials.gov registry record · Phase 1
A First-in-human Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
A Phase 1 study of Healthy and Celiac Disease, sponsored by Nielsen Fernandez-Becker.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT07063823: Recruiting Phase 1 study of Healthy and Celiac Disease, sponsored by Nielsen Fernandez-Becker.
NCT07063823 is a Phase 1 study of Healthy and Celiac Disease that is actively recruiting participants, run by Nielsen Fernandez-Becker. The registered enrollment target is 18 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07063823, a Phase 1 study of Healthy and Celiac Disease, is actively recruiting participants, sponsored by Nielsen Fernandez-Becker.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
Adverse events (AEs) will be recorded and assessed for severity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Conditions Studied
Interventions
- DRUG HB-2121
Study Locations (1)
California
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2025-08-26 |
| Est. Completion | 2026-04-15 |
| Phase | Phase 1 |
What NCT07063823 shows while recruiting
NCT07063823 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which HB-2121 is the first listed.
NCT07063823 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07063823 about?
NCT07063823 is a clinical study titled "A First-in-human 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. 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 ov...
What is the current status of trial NCT07063823?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2025-08-26. Estimated completion is 2026-04-15.
What conditions does trial NCT07063823 study?
This clinical trial studies the following conditions: Healthy, Celiac Disease.
What interventions are being tested in trial NCT07063823?
The interventions under investigation include: HB-2121 (DRUG).
Who is sponsoring clinical trial NCT07063823?
This trial is sponsored by Nielsen Fernandez-Becker, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07063823 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07063823's enrollment target sits among peer trials
18 904th of 1090 higher than 163 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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