VTP-1000 in Adults With Celiac Disease

Recruiting Early Phase 1 Interventional Study
Celiac Disease
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
45 (estimated)
Sponsor
Barinthus Biotherapeutics · Industry
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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 even…
Trial Locations
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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 …
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