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RECRUITINGEarly Phase 1INTERVENTIONAL

VTP-1000 in Adults With Celiac Disease

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - 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 - Non-pregnant or breast feeding females - No other clinical significant findings at screening Who Should NOT Join This Trial: - Refractory celiac disease - Selective IgA deficiency - Positive for HLA-DQ8 - Known wheat allergy or that is Type I hypersensitivity - Active inflammatory bowel disease or other condition with symptoms that will be similar to celiac disease Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 * 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 * Non-pregnant or breast feeding females * No other clinical significant findings at screening Exclusion Criteria: * Refractory celiac disease * Selective IgA deficiency * Positive for HLA-DQ8 * Known wheat allergy or that is Type I hypersensitivity * Active inflammatory bowel disease or other condition with symptoms that will be similar to celiac disease

Treatments Being Tested

BIOLOGICAL

VTP-1000

Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component

OTHER

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