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.
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/dL (2.6 to 4.89 mmol/L) and fasting triglyceride <400 mg/dL (<4.52 mmol/L) that are not on statin or any other lipid lowering therapy.
Body mass index (BMI) between 18 and 35 kg/m2, inclusive, at screening with a body weight of at least 50 kg.
Participants with homozygous and heterozygous familial hypercholesterolemia will be excluded.
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.
Parallel
Inclisiran formulation containing PS80
DrugInclisiran 284 mg
Currently marketed inclisiran formulation
DrugInclisiran 284 mg
Primary plasma PK parameters: Cmax
Cmax = maximum observed plasma concentration
Primary plasma PK parameters: AUClast
AUClast = AUC from time zero to the last measurable concentration sampling time
Primary plasma PK parameters: AUCinf
AUCinf = AUC from time zero to infinity
Additional PK parameters: AUC0-24hr
AUC0-24hr = AUC from time zero to 24 hours
Number of participants with AEs
Number of participants with AEs, including abnormal vital signs, ECGs, injection site reactions and safety laboratory parameters.
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