VTP-1000 in Adults With Celiac Disease
Public ClinicalTrials.gov record NCT06310291. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, First in Human, Randomized, Placebo-controlled Trial With a Controlled Gluten Challenge to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VTP-1000 in Adults With Celiac Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06310291
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Early Phase 1
- Enrollment
- 45 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2024
- Primary completion
- Oct 31, 2026
- Completion
- Oct 31, 2026
- Last update posted
- Jun 17, 2026
2024 – 2026
United States locations
- U.S. sites
- 16
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Parexel EPCU LA | Los Angeles | California | 91206 | Recruiting |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | Recruiting |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | Recruiting |
| GCP Research | St. Petersburg | Florida | 33705 | Recruiting |
| Parexel EPCU Baltimore | Baltimore | Maryland | 21225 | Recruiting |
| Clinical Research Institute of Michigan | Clinton Township | Michigan | 48038 | Recruiting |
| West Michigan Clinical Research Center | Wyoming | Michigan | 49159 | Recruiting |
| Mayo Clinic | Rochester | Minnesota | 55905 | Recruiting |
| NYU Langone - Gastroenterology Associates | New York | New York | 10016 | Recruiting |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | Recruiting |
| Centricity Research | Columbus | Ohio | 43213 | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Recruiting |
| PPD Research Unit | Austin | Texas | 78744 | Recruiting |
| Velocity Clinical Research, Salt Lake City | West Jordan | Utah | 84088 | Recruiting |
| Clinical Research Partners | Richmond | Virginia | 23226 | Recruiting |
| Velocity Clinical Research, Seattle | Seattle | Washington | 98105 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06310291, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 17, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06310291 live on ClinicalTrials.gov.