VTP-1000 in Adults With Celiac Disease
Key facts
- Who runs it
- Barinthus Biotherapeutics
- Where
- Austin, Baltimore, Clinton Township, Colorado Springs, Columbus, Jacksonville, Los Angeles, Nashville, New York, Raleigh, Richmond, Rochester, Seattle, St. Petersburg, West Jordan, and Wyoming, United StatesSee the 16 sites
- Trial code
- Status
- Active, not recruiting
- Phase
- Early phase 1
- People taking part
- 42 people enrolled
- Started
- 1 Aug 2024
- Expected to end
- Nov 2026
- Type of study
- Interventional, 8 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- VTP-1000
- Matched Placebo
- Record updated
- 4 November 2026
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- Refractory celiac disease
- 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
- Selective IgA deficiency
- Positive for HLA-DQ8
Where in United States
- PPD Research UnitAustin, United StatesNo longer taking part
- Parexel EPCU BaltimoreBaltimore, United StatesNo longer taking part
- Clinical Research Institute of MichiganClinton Township, United StatesNo longer taking part
- Peak Gastroenterology AssociatesColorado Springs, United StatesNo longer taking part
- Centricity ResearchColumbus, United StatesNo longer taking part
- Jacksonville Center for Clinical ResearchJacksonville, United StatesNo longer taking part
- Parexel EPCU LALos Angeles, United StatesNo longer taking part
- Vanderbilt University Medical CenterNashville, United StatesNo longer taking part
- NYU Langone Gastroenterology AssociatesNew York, United StatesNo longer taking part
- North Carolina Clinical ResearchRaleigh, United StatesNo longer taking part
- Clinical Research PartnersRichmond, United StatesNo longer taking part
- Mayo ClinicRochester, United StatesNo longer taking part
- Velocity Clinical Research, SeattleSeattle, United StatesNo longer taking part
- GCP ResearchSt. Petersburg, United StatesNo longer taking part
- Velocity Clinical Research, Salt Lake CityWest Jordan, United StatesNo longer taking part
- West Michigan Clinical Research CenterWyoming, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 8 groups in the trial
- Matched Placebo (SAD)Placebo, for comparison
2 placebo comparators; 1 for each part of the study
Treatment: Matched Placebo
- VTP-1000 Dose 1 (SAD)Treatment being tested
3 dose levels in SAD and MAD parts of trial
Treatment: VTP-1000
- VTP-1000 Dose 2 (SAD)Treatment being tested
3 dose levels in SAD and MAD parts of trial
Treatment: VTP-1000
- VTP-1000 Dose 3 (SAD)Treatment being tested
3 dose levels in SAD and MAD parts of trial
Treatment: VTP-1000
- Matched Placebo (MAD)Placebo, for comparison
2 placebo comparators; 1 for each part of the study
Treatment: Matched Placebo
- VTP-1000 Dose 1 (MAD)Treatment being tested
3 dose levels in SAD and MAD parts of trial
Treatment: VTP-1000
- VTP-1000 Dose 2 (MAD)Treatment being tested
3 dose levels in SAD and MAD parts of trial
Treatment: VTP-1000
- VTP-1000 Dose 3 (MAD)Treatment being tested
3 dose levels in SAD and MAD parts of trial
Treatment: VTP-1000
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 4 November 2026