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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 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.

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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

Conditions Studied

Interventions

  • DRUG HB-2121

Study Locations (1)

California

  • Stanford University - Stanford

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2025-08-26
Est. Completion 2026-04-15
Phase Phase 1

Sponsor

Nielsen Fernandez-Becker

3 total trials

What the Registry Record Tells You About NCT07063823

The ClinicalTrials.gov registry entry for NCT07063823 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The listed sponsor is Nielsen Fernandez-Becker, which has 3 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.