VTP-1000 in Adults With Celiac Disease
ConditionCeliac Disease
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBarinthus Biotherapeutics
About this trial
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
Qualifiers
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
Disqualifiers
Refractory celiac disease
Selective IgA deficiency
Positive for HLA-DQ8
Known wheat allergy or that is Type I hypersensitivity
Trial design
Treatments tested in this trial
- VTP-1000
- Matched Placebo
Treatment groups
45 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Locations
16California
Parexel EPCU LA91206, Los Angeles United States
Colorado
Peak Gastroenterology Associates80907, Colorado Springs United States
Florida
Jacksonville Center for Clinical Research32216, Jacksonville United States
GCP Research33705, St. Petersburg United States
Sponsors and collaborators
Barinthus Biotherapeutics
Lead sponsor
Source ClinicalTrials.gov