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VTP-1000 in Adults With Celiac Disease
Sponsor: Barinthus Biotherapeutics
Summary
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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2024-08-01
Completion Date
2026-06
Last Updated
2026-01-09
Healthy Volunteers
No
Conditions
Interventions
VTP-1000
Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component
Matched Placebo
Intramuscular (IM) injection comprised of saline solution
Locations (16)
Parexel EPCU LA
Los Angeles, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
GCP Research
St. Petersburg, Florida, United States
Parexel EPCU Baltimore
Baltimore, Maryland, United States
Clinical Research Institute of Michigan
Clinton Township, Michigan, United States
West Michigan Clinical Research Center
Wyoming, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
NYU Langone - Gastroenterology Associates
New York, New York, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
Centricity Research
Columbus, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
PPD Research Unit
Austin, Texas, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
Clinical Research Partners
Richmond, Virginia, United States
Velocity Clinical Research, Seattle
Seattle, Washington, United States