[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"inclisiran-formulation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:inclisiran-formulation":28},{"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":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100640209","phase-1-assessment-of-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-a-new-formulation-of-inclisiran-containing-polysorbate-80-compared-to-the-currently-marketed-formulation-100640209",false,"NCT07626281","Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation","A Randomized, Open-label, Single-dose, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Inclisiran Containing Polysorbate 80 Versus Inclisiran Alone in Participants With Elevated Low-density Lipoprotein Cholesterol","Inclusion Criteria:\n\n* Healthy male and female (non-childbearing potential) participants between 18 and 60 years of age (inclusive) with fasting serum LDL-C between 100 and 189 mg\u002FdL (2.6 to 4.89 mmol\u002FL) and fasting triglyceride \\\u003C400 mg\u002FdL (\\\u003C4.52 mmol\u002FL) that are not on statin or any other lipid lowering therapy.\n* Body mass index (BMI) between 18 and 35 kg\u002Fm2, inclusive, at screening with a body weight of at least 50 kg.\n\nExclusion Criteria:\n\n* Participants with homozygous and heterozygous familial hypercholesterolemia will be excluded.\n* Historical or current use of any statin (i.e. study participants must be statin naive), other oral LDL-C-lowering medication or supplements that in investigators' judgment may affect serum LDL-C levels.\n\nOther protocol inclusion\u002Fexclusion criteria may apply",true,"ALL","18 Years","60 Years",{"count":21,"type":22},152,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of this study is to compare safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the currently marketed formulation of inclisiran with a new formulation containing polysorbate 80 (PS80), after a single 284 mg subcutaneous (SC) administration.",[28],"Inclisiran Formulation",[30,31,32,33,34,35],"Inclisiran containing polysorbate 80","healthy male and female participants","safety","tolerability","pharmacokinetics","pharmacodynamics","RECRUITING","2026-10-01",{"date":39,"type":40},"2026-10-05","ACTUAL",{"date":42,"type":40},"2026-06-09",{"date":44,"type":22},"2026-12-21",{"name":46,"class":47},"Novartis Pharmaceuticals","INDUSTRY",6]