VTP-1000 in Adults With Celiac Disease

June 9, 2026 updated by: Barinthus Biotherapeutics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

VTP-1000 is a gluten-derived (GLU) peptide immunotherapy that is designed to induce antigen-specific immune tolerance against gluten in patients with celiac disease. The technology underlying VTP-1000 consists of the sponsor's proprietary self-assembling nanoparticles based on amphiphilic peptides tolerance immunotherapy (SNAP-TI) platform which has been configured to package 12 GLU peptide antigens and rapamycin into nanoparticles of ~20 nm diameter.

The goal of treatment with VTP-1000 is to induce tolerance to gluten in patients with coeliac disease by activating antigen-specific regulatory T (Treg) cells that promote tolerance and reducing pre-existing, pathogenic antigen-specific effector T (Teff) cells that underly disease pathogenesis. In turn, this may allow for better management of the condition.

GLU001 is a multi-center phase I first in human study to assess the safety and tolerability of VTP-1000 in adults with celiac disease. The trial also aims to demonstrate proof-of-principle of induction of immune tolerance and early proof-of-concept for VTP-1000 as a potential treatment for coeliac disease based on assessment of pharmacodynamics and preliminary efficacy determined by means of a controlled gluten challenge.

GLU001 will be conducted as a randomized double-blind placebo-controlled study in two parts - Part A and Part B. Part A will be a single ascending dose (SAD) followed by Part B a multiple ascending dose (MAD) which incorporates a gluten challenge.

Part A (Single Ascending Dose)

A stepwise single dose escalation of 3 dose levels of VTP-1000 is planned. A total of 6 participants will be treated at each dose level (4 will receive VTP-1000 and 2 will receive matched placebo). A sentinel dosing approach will be followed, with the first 2 participants randomized to receive VTP1000 or placebo in a 1:1 ratio. Subsequent participants will be randomized in a 3:1 ratio at least 7 days after the second sentinel participant has received trial intervention. Participants will be screened for eligibility up to 28 days prior treatment. Participants will be followed for 21 days after dosing including a 3-day domicile period following administration of VTP-1000.

Part B (Multiple Ascending Dose)

A stepwise multiple dose escalation of up to 3 dose levels of VTP-1000 is planned. A total of 8 participants will be treated at each dose level (6 will receive VTP-1000 and 2 will receive matched placebo). A sentinel dosing approach will be followed in the first dose level only, with the first 2 participants randomized to receive VTP1000 or placebo in a 1:1 ratio. Subsequent participants at the first dose level will be randomized in a 5:1 ratio at least 7 days after the second sentinel participant has received trial intervention. Participants in the second and third dose levels will be randomized in a 6:2 ratio, and no sentinel dosing sequence will be applied.

Participants will be screened for eligibility up to 28 days prior to the start of treatment. Eligible participants will receive 3 doses of trial intervention every 2 weeks at a given dose level with and followed for 57 days. After completion of the third dose of trial intervention, participants will undergo a gluten challenge.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 91206
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Peak Gastroenterology Associates
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • Jacksonville Center for Clinical Research
        • Contact:
      • St. Petersburg, Florida, United States, 33705
    • Maryland
      • Baltimore, Maryland, United States, 21225
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Recruiting
        • Clinical Research Institute of Michigan
        • Contact:
      • Wyoming, Michigan, United States, 49159
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • New York
      • New York, New York, United States, 10016
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • North Carolina Clinical Research
        • Contact:
    • Ohio
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
    • Texas
      • Austin, Texas, United States, 78744
        • Recruiting
        • PPD Research Unit
        • Contact:
    • Utah
      • West Jordan, Utah, United States, 84088
    • Virginia
      • Richmond, Virginia, United States, 23226
    • Washington
      • Seattle, Washington, United States, 98105

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Matched Placebo (SAD)
2 placebo comparators; 1 for each part of the study
Other: Matched Placebo
Intramuscular (IM) injection comprised of saline solution
Experimental: VTP-1000 Dose 1 (SAD)
3 dose levels in SAD and MAD parts of trial
Biological: VTP-1000
Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component
Experimental: VTP-1000 Dose 2 (SAD)
3 dose levels in SAD and MAD parts of trial
Biological: VTP-1000
Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component
Experimental: VTP-1000 Dose 3 (SAD)
3 dose levels in SAD and MAD parts of trial
Biological: VTP-1000
Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component
Placebo Comparator: Matched Placebo (MAD)
2 placebo comparators; 1 for each part of the study
Other: Matched Placebo
Intramuscular (IM) injection comprised of saline solution
Experimental: VTP-1000 Dose 1 (MAD)
3 dose levels in SAD and MAD parts of trial
Biological: VTP-1000
Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component
Experimental: VTP-1000 Dose 2 (MAD)
3 dose levels in SAD and MAD parts of trial
Biological: VTP-1000
Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component
Experimental: VTP-1000 Dose 3 (MAD)
3 dose levels in SAD and MAD parts of trial
Biological: VTP-1000
Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Incidence and severity of treatment-emergent adverse events (TEAEs) , Serious Adverse Events (SAEs) , Adverse Events of Special Interest (AESIs) and adverse events leading to trial intervention discontinuation or trial withdrawal according to NCI CTCAE Version 5.0
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 clinical laboratory safety parameters according to NCI CTCAE Version 5.0
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.
Measurement of in standard clinical laboratory safety parameters according to NCI CTCAE Version 5.0
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.
Measurement of standard hematology clinical laboratory safety parameters according to NCI CTCAE Version 5.0
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.
Measurement of standard urinalysis clinical laboratory safety parameters according to NCI CTCAE Version 5.0
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 12-lead ECG parameters recorded according to NCI CTCAE Version 5.0
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.
Changes from baseline and clinically significant abnormalities in vital signs according to NCI CTCAE Version 5.0
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.
Measurement of anti tTG immunoglobulin at screening and post treatment
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.
Full physical examination required at screening; symptom-directed physical examination at all other clinic visits. Each physical examination must include a review of the administration sites.
Participants will be assessed for up to 21 days and 57 days post first dose for SAD and MAD parts of the study respectively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PART A SAD:Maximum concentration in plasma (Cmax) rapamycin component
Time Frame: SAD Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).
Blood concentration of the rapamycin component of VTP1000 at specified timepoints measured using a liquid chromatography tandem mass spectrometry (LC-MS/MS) method and standard pharmacokinetic parameters
SAD Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).
PART A SAD: Time corresponding to Cmax (Tmax) of rapamycin component
Time Frame: Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).
Blood concentration of the rapamycin component of VTP1000 at specified timepoints measured using a liquid chromatography tandem mass spectrometry (LC-MS/MS) method and standard pharmacokinetic parameters
Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).
AUC from time 0 to last quantifiable concentration (AUC0-t) of rapamycin component
Time Frame: Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).
Blood concentration of the rapamycin component of VTP1000 at specified timepoints measured using a liquid chromatography tandem mass spectrometry (LC-MS/MS) method and standard pharmacokinetic parameters
Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).
AUC extrapolated to infinity (AUC0-∞)of rapamycin component
Time Frame: Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).
Blood concentration of the rapamycin component of VTP1000 at specified timepoints measured using a liquid chromatography tandem mass spectrometry (LC-MS/MS) method and standard pharmacokinetic parameters
Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).
Half-life of rapamycin component
Time Frame: Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).
Blood concentration of the rapamycin component of VTP1000 at specified timepoints measured using a liquid chromatography tandem mass spectrometry (LC-MS/MS) method and standard pharmacokinetic parameters
Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).
Clearance of rapamycin component
Time Frame: Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).
Blood concentration of the rapamycin component of VTP1000 at specified timepoints measured using a liquid chromatography tandem mass spectrometry (LC-MS/MS) method and standard pharmacokinetic parameters
Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).
Volume of distribution of rapamycin component
Time Frame: Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).
Blood concentration of the rapamycin component of VTP1000 at specified timepoints measured using a liquid chromatography tandem mass spectrometry (LC-MS/MS) method and standard pharmacokinetic parameters
Day 1 pre-dose; 0.083 hours* (±2 minutes), 0.25 hours* (±5 minutes), 0.5 hours (±5 minutes), 1 hour (±5 minutes), 2 hours (±5 minutes), 4 hours (±10 minutes), 8 hours (±10 minutes), 24 hours (±30 minutes), 48 hours (±2 hours), 120 hours (±3 hours).
Part B MAD:Maximum concentration in plasma (Cmax) rapamycin component
Time Frame: Part B (MAD): Days 1, 15 and 29 pre-dose and 4 hours (±10 minutes) post-dose; Day 43 pre-challenge and Day 50
The Maximum concentration in plasma (Cmax) results will be reviewed from Part A (SAD) and the Part B (MAD) schedule may be updated accordingly to include additional sampling timepoints and inclusion of the derivation of pharmacokinetic parameters, as applicable.
Part B (MAD): Days 1, 15 and 29 pre-dose and 4 hours (±10 minutes) post-dose; Day 43 pre-challenge and Day 50
Part B MAD:Time corresponding to Cmax (Tmax) of rapamycin component
Time Frame: Part B (MAD): Days 1, 15 and 29 pre-dose and 4 hours (±10 minutes) post-dose; Day 43 pre-challenge and Day 50
The Cmax(Tmax) results will be reviewed from Part A (SAD) and the Part B (MAD) schedule may be updated accordingly to include additional sampling timepoints and inclusion of the derivation of pharmacokinetic parameters, as applicable.
Part B (MAD): Days 1, 15 and 29 pre-dose and 4 hours (±10 minutes) post-dose; Day 43 pre-challenge and Day 50
Part B MAD:AUC from time 0 to last quantifiable concentration (AUC0-t) of rapamycin component
Time Frame: Part B (MAD): Days 1, 15 and 29 pre-dose and 4 hours (±10 minutes) post-dose; Day 43 pre-challenge and Day 50
The AUC from time 0 to last quantifiable concentration (AUC0-t) results will be reviewed from Part A (SAD) and the Part B (MAD) schedule may be updated accordingly to include additional sampling timepoints and inclusion of the derivation of pharmacokinetic parameters, as applicable.
Part B (MAD): Days 1, 15 and 29 pre-dose and 4 hours (±10 minutes) post-dose; Day 43 pre-challenge and Day 50
Part B MAD:AUC extrapolated to infinity (AUC0-∞)of rapamycin component
Time Frame: Part B (MAD): Days 1, 15 and 29 pre-dose and 4 hours (±10 minutes) post-dose; Day 43 pre-challenge and Day 50
The pharmacokinetic results will be reviewed from Part A (SAD) and the Part B (MAD) schedule may be updated accordingly to include additional sampling timepoints and inclusion of the derivation of pharmacokinetic parameters, as applicable.
Part B (MAD): Days 1, 15 and 29 pre-dose and 4 hours (±10 minutes) post-dose; Day 43 pre-challenge and Day 50
Part B MAD: Half-life of rapamycin component
Time Frame: Part B (MAD): Days 1, 15 and 29 pre-dose and 4 hours (±10 minutes) post-dose; Day 43 pre-challenge and Day 50
The Half-life results will be reviewed from Part A (SAD) and the Part B (MAD) schedule may be updated accordingly to include additional sampling timepoints and inclusion of the derivation of pharmacokinetic parameters, as applicable.
Part B (MAD): Days 1, 15 and 29 pre-dose and 4 hours (±10 minutes) post-dose; Day 43 pre-challenge and Day 50
Part B MAD: Clearance of rapamycin component
Time Frame: Part B (MAD): Days 1, 15 and 29 pre-dose and 4 hours (±10 minutes) post-dose; Day 43 pre-challenge and Day 50
The clearance of rapamycin component results will be reviewed from Part A (SAD) and the Part B (MAD) schedule may be updated accordingly to include additional sampling timepoints and inclusion of the derivation of pharmacokinetic parameters, as applicable.
Part B (MAD): Days 1, 15 and 29 pre-dose and 4 hours (±10 minutes) post-dose; Day 43 pre-challenge and Day 50

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gluten Antigen-specific T Cell Responses - Enzyme linked immunospot (ELISpot)
Time Frame: Part A (SAD): Day 1 pre-dose, Days 8 and 15 Part B (MAD): Day 1 pre-dose, Days 8, 22 and 36, Day 43 pre-challenge, Days 50 and 57
Peripheral Blood Mononucleocytes (PBMCs) will be isolated at the trial site or at a Central Laboratory. Following PBMC isolation, analysis of the magnitude of gluten antigen-specific T cell responses (Treg and Teff) in peripheral blood will be performed by the sponsor using enzyme linked immunospot (ELISpot)
Part A (SAD): Day 1 pre-dose, Days 8 and 15 Part B (MAD): Day 1 pre-dose, Days 8, 22 and 36, Day 43 pre-challenge, Days 50 and 57
T cell receptor (TCR) sequencing
Time Frame: Part A (SAD): Day 1 pre-dose, Day 15 Part B (MAD): Day 1 pre-dose, Day 43 pre-challenge and Day 57
Whole Blood sampling with sequencing The whole blood will be isolated, frozen and stored at -80°C until shipped for analysis. Full details on blood sample collection, processing and handling requirements will be provided in the Laboratory Manual
Part A (SAD): Day 1 pre-dose, Day 15 Part B (MAD): Day 1 pre-dose, Day 43 pre-challenge and Day 57
Serum Cytokine Concentrations
Time Frame: SAD Day 1 pre-dose, 4 hours and 24 hours postdose MAD: Days 1, 15 and 29 pre-dose and 4 hours post-dose

2 mL whole blood samples will be drawn for evaluation of Interleukin 2 (IL-2) in serum.Samples will be stored at -80°C until shipped to a Central Laboratory for analysis. Full details on blood sample collection, processing and handling requirements will be provided in the Laboratory Manual.

Analysis of IL-2 concentration (and optionally additional cytokines) will be performed at the Central Laboratory using a multiplex cytokine (Meso Scale Discovery S-plex) method as specified in the respective Analytical Protocol.
SAD Day 1 pre-dose, 4 hours and 24 hours postdose MAD: Days 1, 15 and 29 pre-dose and 4 hours post-dose
Cytokine Whole Blood Stimulation
Time Frame: Part A (SAD): Day 1 pre-dose, Days 8 and 15 Part B (MAD): Day 1 pre-dose, Days 8, 22 and 36, Day 43 pre-challenge and Days 50 and 57

Five 4 mL samples will be drawn and transferred to Greiner Item Number 454088 Vacuette® tubes containing stimulation cocktails for evaluation of cytokines in whole blood stimulated with GLU peptide antigens.Samples will be incubated for 24 hours before processing to sera and stored at -80°C until shipped for analysis. Full details on blood sample collection, processing and handling requirements will be provided in the Laboratory Manual.

Analysis of sera will be performed at a Central Laboratory using a single or multiplex cytokine method as specified in the respective Analytical Protocol.
Part A (SAD): Day 1 pre-dose, Days 8 and 15 Part B (MAD): Day 1 pre-dose, Days 8, 22 and 36, Day 43 pre-challenge and Days 50 and 57

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barinthus Biotherapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 16, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLU001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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