VTP-1000 in Adults With Celiac Disease

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.

Conditions

Celiac Disease

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Study Overview

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Study Details

Study overview

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.

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

VTP-1000 in Adults With Celiac Disease

Condition
Celiac Disease
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Parexel EPCU LA, Los Angeles, California, United States, 91206

Baltimore

Parexel EPCU Baltimore, Baltimore, Maryland, United States, 21225

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Barinthus Biotherapeutics,

Study Record Dates

2026-06