RECRUITING

VTP-1000 in Adults With Celiac Disease

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-08
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06310291

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of celiac disease as confirmed by positive serology and intestinal histology
  2. * Presence of Human Leukocyte Antigen (HLA)-DQ2.5 genotype
  3. * Participants who are on a well controlled gluten restricted diet
  4. * Negative or weak positive anti-tissue transglutaminase (tTG) IgA antibodies and negative or weak positive anti-deamidated gliadin peptide IgG (anti-DGP)-IgA/IgA antibodies
  5. * Non-pregnant or breast feeding females
  6. * No other clinical significant findings at screening
  1. * Refractory celiac disease
  2. * Selective IgA deficiency
  3. * Positive for HLA-DQ8
  4. * Known wheat allergy or that is Type I hypersensitivity
  5. * Active inflammatory bowel disease or other condition with symptoms that will be similar to celiac disease

Contacts and Locations

Study Locations (Sites)

Parexel EPCU LA
Los Angeles, California, 91206
United States
Parexel EPCU Baltimore
Baltimore, Maryland, 21225
United States

Collaborators and Investigators

Sponsor: Barinthus Biotherapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-08
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Celiac Disease