protocolSection identificationModule nctId: NCT06310291, orgStudyIdInfo id: GLU001, briefTitle: VTP-1000 in Adults With Celiac Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Barinthus Biotherapeutics, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Celiac Disease, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: 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, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: VTP-1000, interventions name: Matched Placebo, outcomesModule primaryOutcomes measure: Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest (AESIs), primaryOutcomes measure: Changes from baseline and clinically significant abnormalities in standard Clinical Chemistry laboratory safety parameters, primaryOutcomes measure: Changes from baseline and clinically significant abnormalities in standard Coagulation laboratory safety parameters, primaryOutcomes measure: Changes from baseline and clinically significant abnormalities in standard hematology laboratory safety parameters, primaryOutcomes measure: Changes from baseline and clinically significant abnormalities in standard urinalysis laboratory safety parameters, primaryOutcomes measure: Changes from baseline and clinically significant abnormalities 12-lead electrocardiogram (ECG) parameters, primaryOutcomes measure: Changes from baseline and clinically significant abnormalities in vital signs, primaryOutcomes measure: Number of participants with changes from baseline in anti-tissue transglutaminase (anti-tTG) immunoglobulin A (IgA) antibodies, primaryOutcomes measure: Changes in physical examination findings, secondaryOutcomes measure: PART A SAD:Maximum concentration in plasma (Cmax) rapamycin component, secondaryOutcomes measure: PART A SAD: Time corresponding to Cmax (Tmax) of rapamycin component, secondaryOutcomes measure: AUC from time 0 to last quantifiable concentration (AUC0-t) of rapamycin component, secondaryOutcomes measure: AUC extrapolated to infinity (AUC0-∞)of rapamycin component, secondaryOutcomes measure: Half-life of rapamycin component, secondaryOutcomes measure: Clearance of rapamycin component, secondaryOutcomes measure: Volume of distribution of rapamycin component, secondaryOutcomes measure: Part B MAD:Maximum concentration in plasma (Cmax) rapamycin component, secondaryOutcomes measure: Part B MAD:Time corresponding to Cmax (Tmax) of rapamycin component, secondaryOutcomes measure: Part B MAD:AUC from time 0 to last quantifiable concentration (AUC0-t) of rapamycin component, secondaryOutcomes measure: Part B MAD:AUC extrapolated to infinity (AUC0-∞)of rapamycin component, secondaryOutcomes measure: Part B MAD: Half-life of rapamycin component, secondaryOutcomes measure: Part B MAD: Clearance of rapamycin component, otherOutcomes measure: Gluten Antigen-specific T Cell Responses - Enzyme linked immunospot (ELISpot), otherOutcomes measure: Gluten Antigen-specific T Cell Responses - Intracellular cytokine staining (ICS), otherOutcomes measure: T cell receptor (TCR) sequencing, otherOutcomes measure: Serum Cytokine Concentrations, otherOutcomes measure: Cytokine Whole Blood Stimulation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False