NCT06310291 VTP-1000 in Adults With Celiac Disease
| NCT ID | NCT06310291 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Barinthus Biotherapeutics |
| Condition | Celiac Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 45 participants in total. It began in 2024-08-01 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of celiac disease as confirmed by positive serology and intestinal histology * Presence of Human Leukocyte Antigen (HLA)-DQ2.5 genotype * Participants who are on a well controlled gluten restricted diet * Anti-tissue transglutaminase (tTG) IgA antibodies less than 2 times the upper limit of normal and anti-deamidated gliadin peptide IgG (anti-DGP)-IgA/IgA antibodies less than 3 times the upper limit of normal * Non-pregnant or breast feeding females * No other clinical significant findings at screening Exclusion Criteria: * Refractory celiac disease * Selective IgA deficiency * Positive for HLA-DQ8 * Known wheat allergy or that is Type I hypersensitivity * Active inflammatory bowel disease or other condition with symptoms that will be similar to celiac disease
Frequently Asked Questions
Who can join the NCT06310291 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Celiac Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06310291 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06310291 currently recruiting?
Yes, NCT06310291 is actively recruiting participants. Visit ClinicalTrials.gov or contact Barinthus Biotherapeutics to inquire about joining.
Where is the NCT06310291 trial being conducted?
This trial is being conducted at Los Angeles, United States, Colorado Springs, United States, Jacksonville, United States, St. Petersburg, United States and 11 additional locations.
Who is sponsoring the NCT06310291 clinical trial?
NCT06310291 is sponsored by Barinthus Biotherapeutics. The trial plans to enroll 45 participants.