Recruiting
Early Phase 1

VTP-1000

Sponsor:

Barinthus Biotherapeutics

Code:

NCT06310291

Conditions

Celiac Disease

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

VTP-1000

Matched Placebo

Study Details

Brief 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.

Conditions

Celiac Disease

Study ID

NCT06310291

Start date

Aug 1, 2024

Status verified date

Jun, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Matched Placebo (SAD)

2 placebo comparators; 1 for each part of the study

experimental: VTP-1000 Dose 1 (SAD)

3 dose levels in SAD and MAD parts of trial

experimental: VTP-1000 Dose 2 (SAD)

3 dose levels in SAD and MAD parts of trial

experimental: VTP-1000 Dose 3 (SAD)

3 dose levels in SAD and MAD parts of trial

placebo comparator: Matched Placebo (MAD)

2 placebo comparators; 1 for each part of the study

experimental: VTP-1000 Dose 1 (MAD)

3 dose levels in SAD and MAD parts of trial

experimental: VTP-1000 Dose 2 (MAD)

3 dose levels in SAD and MAD parts of trial

experimental: VTP-1000 Dose 3 (MAD)

3 dose levels in SAD and MAD parts of trial

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

Primary outcome measure

  • Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest (AESIs) [ Time Frame: Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively. ]
  • Changes from baseline and clinically significant abnormalities in standard Clinical Chemistry laboratory safety parameters [ Time Frame: Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively. ]
  • Changes from baseline and clinically significant abnormalities in standard Coagulation laboratory safety parameters [ Time Frame: Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively. ]
  • Changes from baseline and clinically significant abnormalities in standard hematology laboratory safety parameters [ Time Frame: Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively. ]
  • Changes from baseline and clinically significant abnormalities in standard urinalysis laboratory safety parameters [ Time Frame: Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively. ]
  • Changes from baseline and clinically significant abnormalities 12-lead electrocardiogram (ECG) parameters [ Time Frame: Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively. ]
  • Changes from baseline and clinically significant abnormalities in vital signs [ Time Frame: Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively. ]
  • Number of participants with changes from baseline in anti-tissue transglutaminase (anti-tTG) immunoglobulin A (IgA) antibodies [ Time Frame: Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively. ]
  • Changes in physical examination findings [ Time Frame: Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively. ]

Central Contacts and Locations

Locations

Parexel EPCU LA

Recruiting

Los Angeles, California, United States, 91206

Contacts

Jess Mehrasaz

626-298-2756jess.mehrsaz@parexel.com

Peak Gastroenterology Associates

Recruiting

Colorado Springs, Colorado, United States, 80907

Contacts

Rutva Nakarani

719-636-1201rnakarani@peakgastro.com

Jacksonville Center for Clinical Research

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Sara Villotti

904-730-0101svillotti@encoredocs.com

GCP Research

Recruiting

St. Petersburg, Florida, United States, 33705

Contacts

Jessica Cruz

727-520-1427jcruz@researchgcp.com

Parexel EPCU Baltimore

Recruiting

Baltimore, Maryland, United States, 21225

Contacts

Jess Mehrsaz

626-298-2756jess.mehrsaz@parexel.com

Clinical Research Institute of Michigan

Recruiting

Clinton Township, Michigan, United States, 48038

Contacts

Molly Wythe

586-598-3329mwythe@researchmi.com

West Michigan Clinical Research Center

Recruiting

Wyoming, Michigan, United States, 49159

Contacts

Rochelle Copeland

616-328-5344rcopeland@gastro-assoc-wm.com

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Chadrick Hinson

507-266-0237Hinson.chadrick@mayo.edu

NYU Langone - Gastroenterology Associates

Recruiting

New York, New York, United States, 10016

Contacts

Valeria Pasuizaca-Yanez

212-263-3095Valeria.Pasuizaca-Yanez@nyulangone.org

North Carolina Clinical Research

Recruiting

Raleigh, North Carolina, United States, 27607

Contacts

Daunita Audesuyi

919-881-0309dadesuyi@nccr.com

Centricity Research

Recruiting

Columbus, Ohio, United States, 43213

Contacts

Stephanie Scarberry

614-501-6164Stephanie.Scarberry@centricityresearch.com

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Mary Vozar

615-936-1288mary.c.vozar@vumc.org

PPD Research Unit

Recruiting

Austin, Texas, United States, 78744

Contacts

Al Gonzalez

512-747-4656Al.Gonzalez@ppd.com

Velocity Clinical Research, Salt Lake City

Recruiting

West Jordan, Utah, United States, 84088

Contacts

Srinivas Mulamalla

801-542-8190smulamalla@velocityclinical.com

Clinical Research Partners

Recruiting

Richmond, Virginia, United States, 23226

Contacts

Aundraya Bray

804-477-3045at@clinicalresearchrva.com

Velocity Clinical Research, Seattle

Recruiting

Seattle, Washington, United States, 98105

Contacts

Luis Casanova

206-710-1574lcasanova@velocityclinical.com

More Information

Sponsor

Barinthus Biotherapeutics

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Barinthus Biotherapeutics on 2026-06-18.