NCT06310291 · Barinthus Biotherapeutics
VTP-1000 in Adults With Celiac Disease
What this study is about
GLU001 is a first-in-human clinical trial to assess the safety and how well patients handle the treatment 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.
View original scientific 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.
Interventions
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
Primary outcome measures
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
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
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
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
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
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
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
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
- Colorado Springs, Colorado
- Jacksonville, Florida
- St. Petersburg, Florida
- Baltimore, Maryland
- Clinton Township, Michigan
- Wyoming, Michigan
- Rochester, Minnesota
- New York, New York
- Raleigh, North Carolina
- Columbus, Ohio
- Nashville, Tennessee
And 4 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations