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RecruitingEarly Phase 1

VTP-1000 in Adults With Celiac Disease

Barinthus Biotherapeutics · NCT06310291

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–70 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Early Phase 1
Target enrollment
45
US sites recruiting
16
Study start
August 1, 2024
Record last updated
June 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: VTP-1000; Matched Placebo

Conditions: Celiac Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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 times the upper limit of normal and anti-deamidated gliadin peptide IgG (anti-DGP)-IgA/IgA antibodies less than 3 times the upper limit of normal
  • 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

Recruiting US locations

  • Parexel EPCU LA

    Los Angeles, CA 91206

    Site contact: Jess Mehrasaz · 626-298-2756 · jess.mehrsaz@parexel.com

  • Peak Gastroenterology Associates

    Colorado Springs, CO 80907

    Site contact: Rutva Nakarani · 719-636-1201 · rnakarani@peakgastro.com

  • Jacksonville Center for Clinical Research

    Jacksonville, FL 32216

    Site contact: Sara Villotti · 904-730-0101 · svillotti@encoredocs.com

  • GCP Research

    St. Petersburg, FL 33705

    Site contact: Jessica Cruz · 727-520-1427 · jcruz@researchgcp.com

  • Parexel EPCU Baltimore

    Baltimore, MD 21225

    Site contact: Jess Mehrsaz · 626-298-2756 · jess.mehrsaz@parexel.com

  • Clinical Research Institute of Michigan

    Clinton Township, MI 48038

    Site contact: Molly Wythe · 586-598-3329 · mwythe@researchmi.com

  • West Michigan Clinical Research Center

    Wyoming, MI 49159

    Site contact: Rochelle Copeland · 616-328-5344 · rcopeland@gastro-assoc-wm.com

  • Mayo Clinic

    Rochester, MN 55905

    Site contact: Chadrick Hinson · 507-266-0237 · Hinson.chadrick@mayo.edu

  • NYU Langone - Gastroenterology Associates

    New York, NY 10016

    Site contact: Valeria Pasuizaca-Yanez · 212-263-3095 · Valeria.Pasuizaca-Yanez@nyulangone.org

  • North Carolina Clinical Research

    Raleigh, NC 27607

    Site contact: Daunita Audesuyi · 919-881-0309 · dadesuyi@nccr.com

  • Centricity Research

    Columbus, OH 43213

    Site contact: Stephanie Scarberry · 614-501-6164 · Stephanie.Scarberry@centricityresearch.com

  • Vanderbilt University Medical Center

    Nashville, TN 37232

    Site contact: Mary Vozar · 615-936-1288 · mary.c.vozar@vumc.org

  • PPD Research Unit

    Austin, TX 78744

    Site contact: Al Gonzalez · 512-747-4656 · Al.Gonzalez@ppd.com

  • Velocity Clinical Research, Salt Lake City

    West Jordan, UT 84088

    Site contact: Srinivas Mulamalla · 801-542-8190 · smulamalla@velocityclinical.com

  • Clinical Research Partners

    Richmond, VA 23226

    Site contact: Aundraya Bray · 804-477-3045 · at@clinicalresearchrva.com

  • Velocity Clinical Research, Seattle

    Seattle, WA 98105

    Site contact: Luis Casanova · 206-710-1574 · lcasanova@velocityclinical.com

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VTP-1000 in Adults With Celiac Disease (NCT06310291) | Bored Studies