protocolSection identificationModule nctId: NCT06372483, orgStudyIdInfo id: VMX-C001-03, secondaryIdInfos id: 2023-507059-32-00, type: CTIS, briefTitle: Single Dose Trial of VMX-C001 in Healthy Subjects With and Without FXa Direct Oral Anticoagulant, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: VarmX B.V., class: INDUSTRY, descriptionModule briefSummary: A single centre, double-blind, randomized, placebo-controlled single dose study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VMX-C001, conducted in two parts:Part 1: Single dose of VMX-C001 or placebo in healthy volunteers.Part 2: Single dose of VMX-C001 or placebo in combination with a selected factor 10a (FXa) direct oral anticoagulant (DOAC) in healthy older subjects., conditionsModule conditions: Coagulation Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Placebo controlled, single dose., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double-blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: VMX-C001, interventions name: Placebo, interventions name: Rivaroxaban 20 mg Oral Tablet, interventions name: Apixaban 5 mg Oral Tablet, interventions name: Edoxaban 60 mg Oral Tablet, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 1), primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 2), primaryOutcomes measure: PK of VMX-C001 in plasma - Cmax, primaryOutcomes measure: PK of VMX-C001 in plasma - tmax, primaryOutcomes measure: PK of VMX-C001 in plasma - t1/2, primaryOutcomes measure: PK of VMX-C001 in plasma - AUC0-last, primaryOutcomes measure: PK of VMX-C001 in plasma - AUC0-inf, primaryOutcomes measure: PK of VMX-C001 in plasma - Lambda z, primaryOutcomes measure: PK of VMX-C001 in plasma - CL, primaryOutcomes measure: PK of VMX-C001 in plasma - Vz, primaryOutcomes measure: DOAC plasma concentrations (Part 2), primaryOutcomes measure: Change in Prothrombin time (PT) following dosing with VMX-C001, primaryOutcomes measure: Change in activated partial thromboplastin time (aPTT) following dosing with VMX-C001, primaryOutcomes measure: Change in D-dimer following dosing with VMX-C001, primaryOutcomes measure: Change in prothrombin fragments F1 and 2 following dosing with VMX-C001, primaryOutcomes measure: Change in thrombin generation, measured by lag time, following dosing with VMX-C001, primaryOutcomes measure: Change in thrombin generation, measured by endogenous thrombin potential, following dosing with VMX-C001, primaryOutcomes measure: Change in thrombin generation, measured by peak height, following dosing with VMX-C001, primaryOutcomes measure: Change in thrombin generation, measured by time to peak, following dosing with VMX-C001, primaryOutcomes measure: Change in thrombin generation, measured by velocity index, following dosing with VMX-C001, primaryOutcomes measure: Change in thrombin generation, measured by time to tail, following dosing with VMX-C001, primaryOutcomes measure: Change in diluted prothrombin time (dPT) following dosing with VMX-C001, primaryOutcomes measure: Change in diluted Russell Viper Venom time (dRVVT) following dosing with VMX-C001, primaryOutcomes measure: Change in real time activated clotting time (ACT) following dosing with VMX-C001, secondaryOutcomes measure: Antibodies against VMX-C001 in plasma, secondaryOutcomes measure: Antibodies against human coagulation FX in plasma, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ICON, status: RECRUITING, city: Groningen, zip: 9728 NZ, country: Netherlands, contacts name: Salah Hadi, MD, role: CONTACT, phone: +31 50 8505 798, email: info@iconclinicaltrials.com, geoPoint lat: 53.21917, lon: 6.56667, hasResults: False