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NCT06310291 · ClinicalTrials.gov registry record · Early Phase 1

VTP-1000 in Adults With Celiac Disease

A Early Phase 1 study of Celiac Disease, sponsored by Barinthus Biotherapeutics.

Recruiting
Registry status
Early Phase 1
Development phase
45
Enrollment target
16
Study locations

NCT06310291 is a Early Phase 1 study of Celiac Disease that is actively recruiting participants, run by Barinthus Biotherapeutics. The registered enrollment target is 45 participants, below the 1,978-participant average among 24 other Celiac Disease trials with a reported enrollment target (98% lower). The trial reports 16 study locations across 14 states.

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The verdict

NCT06310291, a Early Phase 1 study of Celiac Disease, is actively recruiting participants, sponsored by Barinthus Biotherapeutics.

RECRUITING
Registry status
Early Phase 1
Development phase
45 participants
Enrollment target
16
Study locations

Study Summary

GLU001 is a first-in-human clinical trial to assess the safety and tolerability of VTP-1000 for adults with celiac disease. This trial will assess VTP-1000 at various dose levels compared to placebo in a single ascending dose (SAD) and multiple ascending dose (MAD) format. Participants will be followed for a short period of time to assess the impact of VTP-1000 on their immune system (Adverse events, reactions in the blood, and physical exam differences). Participants enrolled in the MAD portion of the trial will undergo a gluten challenge to assess the impact exposure to gluten has on participants after administration of VTP-1000.

Conditions Studied

Celiac Disease

Interventions

  • BIOLOGICAL VTP-1000
  • OTHER Matched Placebo

Study Locations (16)

Florida

  • Jacksonville Center for Clinical Research - Jacksonville
  • GCP Research - St. Petersburg

Michigan

  • Clinical Research Institute of Michigan - Clinton Township
  • West Michigan Clinical Research Center - Wyoming

California

  • Parexel EPCU LA - Los Angeles

Colorado

  • Peak Gastroenterology Associates - Colorado Springs

Maryland

  • Parexel EPCU Baltimore - Baltimore

Minnesota

  • Mayo Clinic - Rochester

New York

  • NYU Langone - Gastroenterology Associates - New York

North Carolina

  • North Carolina Clinical Research - Raleigh

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2024-08-01
Est. Completion 2026-06
Phase Early Phase 1

Sponsor

Barinthus Biotherapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06310291

The ClinicalTrials.gov registry entry for NCT06310291 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,978-participant average among 24 other Celiac Disease trials with a reported enrollment target (98% lower). The listed sponsor is Barinthus Biotherapeutics, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Celiac Disease appearing as the primary indexed condition, and to 2 interventions - of which VTP-1000 is the first listed.

NCT06310291 reports 16 study locations spanning 14 distinct geographic areas - top geographies include Florida, Michigan, California.

Frequently Asked Questions

What is clinical trial NCT06310291 about?

NCT06310291 is a clinical study titled "VTP-1000 in Adults With Celiac Disease". GLU001 is a first-in-human clinical trial to assess the safety and tolerability of VTP-1000 for adults with celiac disease. This trial will assess VTP-1000 at various dose levels compared to placebo in a single ascending dose (SAD) and multiple ascending dose (MAD) format. Participants will be follo...

What is the current status of trial NCT06310291?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 45 participants. The study started on 2024-08-01. Estimated completion is 2026-06.

What conditions does trial NCT06310291 study?

This clinical trial studies the following conditions: Celiac Disease.

What interventions are being tested in trial NCT06310291?

The interventions under investigation include: VTP-1000 (BIOLOGICAL), Matched Placebo (OTHER).

Who is sponsoring clinical trial NCT06310291?

This trial is sponsored by Barinthus Biotherapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06310291 being conducted?

This trial has 16 study locations across California, Colorado, Florida, Maryland, Michigan. 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.