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VTP-1000 in Adults With Celiac Disease
NCT06310291 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2026-06 |
| Phase | Early Phase 1 |
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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. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Barinthus Biotherapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06310291 reports 16 study locations spanning 14 distinct geographic areas — top geographies include Florida, Michigan, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06310291?
The interventions under investigation include: VTP-1000 (BIOLOGICAL), Matched Placebo (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06310291?
This trial is sponsored by Barinthus Biotherapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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