[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626035":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":11,"centralContacts":35,"locations":40,"responsibleParty":59,"collaborators":11,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":11,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":43,"whyStopped":11,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"City Therapeutics","INDUSTRY",[8,14,19,22],{"label":9,"type":10,"description":11,"interventionNames":12},"CITY-FXI in Healthy Adults (Part A)","EXPERIMENTAL",null,[13],"Drug: CITY-FXI",{"label":15,"type":16,"description":11,"interventionNames":17},"In Healthy Adults (Part A)","PLACEBO_COMPARATOR",[18],"Drug: Placebo",{"label":20,"type":10,"description":11,"interventionNames":21},"CITY-FXI in Adults with Factor V Leiden or Prothrombin G20210A Mutation (Part B)",[13],{"label":23,"type":16,"description":11,"interventionNames":24},"In Adults with Factor V Leiden or Prothrombin G20210A Mutation (Part B)",[18],[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"DRUG","CITY-FXI","siRNA (subcutaneous injection)",[20,9],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"Placebo","Saline (subcutaneous injection)",[23,15],[36],{"name":5,"role":37,"phone":38,"phoneExt":11,"email":39},"CONTACT","857-219-5440","clinicaltrials@citytx.com",[41],{"facility":42,"status":43,"city":44,"state":11,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Richmond Pharmacology","RECRUITING","London","SE1 1YR","United Kingdom","UK",{"type":49,"coordinates":50},"Point",[51,52],-0.12574,51.50853,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":11,"email":58},"Dr. Ulrike Lorch","+44 0207 042 5800","volunteer@richmondpharmacology.com",{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100626035","phase-1-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-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":73,"type":74},128,"ESTIMATED","INTERVENTIONAL",[77],"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.",[80,81],"Factor V Leiden","Prothrombin G20210A",[83,84],"Factor XI","siRNA","2026-02-18",{"date":87,"type":88},"2026-02-24","ACTUAL",{"date":90,"type":88},"2026-01-22",{"date":92,"type":74},"2027-10",{"name":5,"class":6},1]