VTP-1000 in Adults With Celiac Disease
Recruiting now · Early Phase 1 · Has a placebo group
Conditions studied: Celiac Disease
In brief
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.
Key facts
- Study ID
- NCT06310291
- Run by
- Barinthus Biotherapeutics
- People needed
- 45
- Starts
- 2024-08-01
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-06-18
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Parexel EPCU LA — Los Angeles, California, United States (enrolling)
- Peak Gastroenterology Associates — Colorado Springs, Colorado, United States (enrolling)
- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States (enrolling)
- GCP Research — St. Petersburg, Florida, United States (enrolling)
- Parexel EPCU Baltimore — Baltimore, Maryland, United States (enrolling)
- Clinical Research Institute of Michigan — Clinton Township, Michigan, United States (enrolling)
- West Michigan Clinical Research Center — Wyoming, Michigan, United States (enrolling)
- Mayo Clinic — Rochester, Minnesota, United States (enrolling)
- NYU Langone - Gastroenterology Associates — New York, New York, United States (enrolling)
- North Carolina Clinical Research — Raleigh, North Carolina, United States (enrolling)
- Centricity Research — Columbus, Ohio, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
- PPD Research Unit — Austin, Texas, United States (enrolling)
- Velocity Clinical Research, Salt Lake City — West Jordan, Utah, United States (enrolling)
- Clinical Research Partners — Richmond, Virginia, United States (enrolling)
- Velocity Clinical Research, Seattle — Seattle, Washington, United States (enrolling)
Full record on ClinicalTrials.gov
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