[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626035":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":40,"studyPopulation":30,"armGroups":41,"interventions":58,"overallOfficials":30,"centralContacts":68,"locations":73,"responsibleParty":92,"collaborators":30,"id":94,"slug":30,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":30,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":30,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":76,"whyStopped":30,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"City Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs)","To evaluate the safety and tolerability of a single dose of CITY-FXI in healthy adults and adults with Factor V Leiden (FVL) or prothrombin G20210A mutation","Through study completion, up to Day 360",[14,18,20,22,26,28],{"measure":15,"description":16,"timeFrame":17},"Maximum plasma concentration (Cmax)","To characterize the pharmacokinetics (PK) of a single dose of CITY-FXI in healthy adults and adults with FVL or prothrombin G20210A mutation","Day -1 to Day 3",{"measure":19,"description":16,"timeFrame":17},"Area under plasma concentration time curve (AUC) of CITY-FXI",{"measure":21,"description":16,"timeFrame":17},"Amount excreted in urine (Ae) of CITY-FXI",{"measure":23,"description":24,"timeFrame":25},"Change from baseline in levels of plasma Factor XI (FXI)","To characterize the pharmacodynamics (PD) of a single dose of CITY-FXI in healthy adults and adults with FVL or prothrombin G20210A mutation","Up to Day 360",{"measure":27,"description":24,"timeFrame":25},"Change from baseline of Factor XI (FXI) activity",{"measure":29,"description":24,"timeFrame":25},"Change from baseline in activated partial thromboplastin time (aPTT)",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":36,"maskingDescription":30,"whoMasked":37},"DOUBLE",[38,39],"PARTICIPANT","INVESTIGATOR","The study will be conducted in two parts:\n\n* Part A: Single Ascending Dose in Healthy Adults\n* Part B: Single Ascending Dose in Adults with Factor V Leiden (FVL) or Prothrombin G20210A Mutation",[42,47,52,55],{"label":43,"type":44,"description":30,"interventionNames":45},"CITY-FXI in Healthy Adults (Part A)","EXPERIMENTAL",[46],"Drug: CITY-FXI",{"label":48,"type":49,"description":30,"interventionNames":50},"In Healthy Adults (Part A)","PLACEBO_COMPARATOR",[51],"Drug: Placebo",{"label":53,"type":44,"description":30,"interventionNames":54},"CITY-FXI in Adults with Factor V Leiden or Prothrombin G20210A Mutation (Part B)",[46],{"label":56,"type":49,"description":30,"interventionNames":57},"In Adults with Factor V Leiden or Prothrombin G20210A Mutation (Part B)",[51],[59,64],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":30},"DRUG","CITY-FXI","siRNA (subcutaneous injection)",[53,43],{"type":60,"name":65,"description":66,"armGroupLabels":67,"otherNames":30},"Placebo","Saline (subcutaneous injection)",[56,48],[69],{"name":5,"role":70,"phone":71,"phoneExt":30,"email":72},"CONTACT","857-219-5440","clinicaltrials@citytx.com",[74],{"facility":75,"status":76,"city":77,"state":30,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Richmond Pharmacology","RECRUITING","London","SE1 1YR","United Kingdom","UK",{"type":82,"coordinates":83},"Point",[84,85],-0.12574,51.50853,{"lat":85,"lon":84},[88],{"name":89,"role":70,"phone":90,"phoneExt":30,"email":91},"Dr. Ulrike Lorch","+44 0207 042 5800","volunteer@richmondpharmacology.com",{"type":93,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100626035",false,"NCT07430397","A Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CITY-FXI in Healthy Adults and Adults With FV Leiden or Prothrombin G20210A Mutation","A Phase 1, Randomised, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CITY-FXI, a FXI Targeting siRNA, Administered Subcutaneously in Healthy Adults and Adults With Factor V Leiden or Prothrombin G20210A Mutation","Inclusion Criteria:\n\n* Males and women of non-childbearing potential (WONCBP) aged 18 to 45 years (Part A only)\n* Male and female participants aged 18 to 60 (Part B only)\n* Body Mass Index (BMI) between 18 and 25 kg\u002Fm2 (inclusive) and a minimum weight of 50 kg\n* Ability and willingness to comply fully with all study procedures and lifestyle considerations\n* Confirmed diagnosis of FVL or prothrombin G20210A mutation via genetic testing (Part B only)\n* Women of childbearing potential (WOCBP) must agree to use acceptable highly effective contraceptive methods (Part B only)\n\nExclusion Criteria:\n\n* Any clinically significant systemic disease or disorder, including but not limited to cardiovascular, hepatic, or oncological conditions\n* History or evidence of any bleeding disorders\n* History of clinically significant spontaneous bleeding\n* Prior treatment with an investigational agent\n* Confirmed diagnosis of homozygous mutations, or combined thrombophilic defects of (Part B only)",true,"ALL","18 Years","60 Years",{"count":105,"type":106},128,"ESTIMATED","INTERVENTIONAL",[109],"PHASE1","This is a first-in-human (FIH), single-center, randomised, double-blind, placebo-controlled, single ascending dose (SAD) study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CITY-FXI in healthy adults and adults with Factor V Leiden (FVL) or prothrombin G20210A mutation.",[112,113],"Factor V Leiden","Prothrombin G20210A",[115,116],"Factor XI","siRNA","2026-02-18",{"date":119,"type":120},"2026-02-24","ACTUAL",{"date":122,"type":120},"2026-01-22",{"date":124,"type":106},"2027-10",{"name":5,"class":6},1]