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.
Sponsors and collaborators
Source ClinicalTrials.gov