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