Celiac DiseaseEarly Phase 1NCT06310291
VTP-1000 in Adults With Celiac Disease
A Early Phase 1 study testing VTP-1000 in people with Celiac Disease, run by Barinthus Biotherapeutics at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- VTP-1000
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 16 sitesUnited States
- Study dates
- 1 Aug 2024to Nov 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
PPD Research Unit
Austin, Texas, 78744
Parexel EPCU Baltimore
Baltimore, Maryland, 21225
Clinical Research Institute of Michigan
Clinton Township, Michigan, 48038
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
Centricity Research
Columbus, Ohio, 43213
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Parexel EPCU LA
Los Angeles, California, 91206
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
NYU Langone - Gastroenterology Associates
New York, New York, 10016
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Clinical Research Partners
Richmond, Virginia, 23226
Mayo Clinic
Rochester, Minnesota, 55905
Velocity Clinical Research, Seattle
Seattle, Washington, 98105
GCP Research
St. Petersburg, Florida, 33705
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088
West Michigan Clinical Research Center
Wyoming, Michigan, 49159
About this study
Official title: 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.
Read the 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.
- Conditions
- Celiac Disease
- Being tested
- VTP-1000, Matched Placebo
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VTP-1000Biological
Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component
Matched PlaceboOther
Intramuscular (IM) injection comprised of saline solution
| Study group | Role | What they receive |
|---|---|---|
| Matched Placebo (SAD) | Placebo comparator | 2 placebo comparators; 1 for each part of the study Receives: Other: Matched Placebo |
| VTP-1000 Dose 1 (SAD) | Experimental | 3 dose levels in SAD and MAD parts of trial Receives: Biological: VTP-1000 |
| VTP-1000 Dose 2 (SAD) | Experimental | 3 dose levels in SAD and MAD parts of trial Receives: Biological: VTP-1000 |
| VTP-1000 Dose 3 (SAD) | Experimental | 3 dose levels in SAD and MAD parts of trial Receives: Biological: VTP-1000 |
| Matched Placebo (MAD) | Placebo comparator | 2 placebo comparators; 1 for each part of the study Receives: Other: Matched Placebo |
| VTP-1000 Dose 1 (MAD) | Experimental | 3 dose levels in SAD and MAD parts of trial Receives: Biological: VTP-1000 |
| VTP-1000 Dose 2 (MAD) | Experimental | 3 dose levels in SAD and MAD parts of trial Receives: Biological: VTP-1000 |
| VTP-1000 Dose 3 (MAD) | Experimental | 3 dose levels in SAD and MAD parts of trial Receives: Biological: VTP-1000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest (AESIs)
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
Measured: 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
Changes from baseline and clinically significant abnormalities in standard clinical laboratory safety parameters according to NCI CTCAE Version 5.0
Measured: 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
Measurement of in standard clinical laboratory safety parameters according to NCI CTCAE Version 5.0
Measured: 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
Measurement of standard hematology clinical laboratory safety parameters according to NCI CTCAE Version 5.0
Measured: 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
Measurement of standard urinalysis clinical laboratory safety parameters according to NCI CTCAE Version 5.0
Measured: 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
Changes from baseline and clinically significant abnormalities in 12-lead ECG parameters recorded according to NCI CTCAE Version 5.0
Measured: 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
Changes from baseline and clinically significant abnormalities in vital signs according to NCI CTCAE Version 5.0
Measured: 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
Measurement of anti tTG immunoglobulin at screening and post treatment
Measured: 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
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.
Measured: 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 outcomes (13)
PART A SAD:Maximum concentration in plasma (Cmax) rapamycin component
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Part B (MAD): Days 1, 15 and 29 pre-dose and 4 hours (±10 minutes) post-dose; Day 43 pre-challenge and Day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Aug 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The Single Ascending Dose part of the trial contains a placebo controlled randomized 4+2 design, where four participants will receive active IMP and two placebo. The Multiple Ascending Dose is a standard sequential design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barinthus Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310291
- Sponsor's protocol ID
- GLU001
- Status last verified
- Nov 2026
- First submitted
- 16 Feb 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06310291
- Acronym / sponsor ID
- GLU001
- Conditions
- Celiac Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Barinthus BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- The Single Ascending Dose part of the trial contains a placebo controlled randomized 4+2 design, where four participants will receive active IMP and two placebo. The Multiple Ascending Dose is a standard sequential design
| Arm | Type | Receives |
|---|---|---|
| Matched Placebo (SAD) | Placebo comparator | Other: Matched Placebo2 placebo comparators; 1 for each part of the study |
| VTP-1000 Dose 1 (SAD) | Experimental | Biological: VTP-10003 dose levels in SAD and MAD parts of trial |
| VTP-1000 Dose 2 (SAD) | Experimental | Biological: VTP-10003 dose levels in SAD and MAD parts of trial |
| VTP-1000 Dose 3 (SAD) | Experimental | Biological: VTP-10003 dose levels in SAD and MAD parts of trial |
| Matched Placebo (MAD) | Placebo comparator | Other: Matched Placebo2 placebo comparators; 1 for each part of the study |
| VTP-1000 Dose 1 (MAD) | Experimental | Biological: VTP-10003 dose levels in SAD and MAD parts of trial |
| VTP-1000 Dose 2 (MAD) | Experimental | Biological: VTP-10003 dose levels in SAD and MAD parts of trial |
| VTP-1000 Dose 3 (MAD) | Experimental | Biological: VTP-10003 dose levels in SAD and MAD parts of trial |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VTP-1000Intramuscular (IM) injection comprised of self-assembling nanoparticles of gluten peptides and a rapamycin component | Biological | VTP-1000 Dose 1 (MAD), VTP-1000 Dose 1 (SAD), VTP-1000 Dose 2 (MAD), VTP-1000 Dose 2 (SAD), VTP-1000 Dose 3 (MAD), VTP-1000 Dose 3 (SAD) |
| Matched PlaceboIntramuscular (IM) injection comprised of saline solution | Other | Matched Placebo (MAD), Matched Placebo (SAD) |
Primary outcome
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.
13 secondary outcomes
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).
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).
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).
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).
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).
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).
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).
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing VTP-1000 in people with Celiac Disease, run by Barinthus Biotherapeutics at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.