[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"City Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"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":21,"type":22},128,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Factor V Leiden","Prothrombin G20210A",[31,32],"Factor XI","siRNA","RECRUITING","2026-02-18",{"date":36,"type":37},"2026-02-24","ACTUAL",{"date":39,"type":37},"2026-01-22",{"date":41,"type":22},"2027-10",{"name":43,"class":44},"City Therapeutics","INDUSTRY",""]