Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation
brief summary
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.
detailed description
This is a randomized, single-dose, open-label, parallel-group, study to evaluate the PK, safety, and tolerability of inclisiran 284 mg. The study drug will be administered as a single SC injection to the abdomen administered as 2 different formulations (the marketed formulation and a test formulation containing PS80). Approximately 152 adult participants (76 per formulation) with elevated serum LDL-C, but otherwise healthy, are planned to be enrolled.
The duration of the study for each participant will be approximately 118 days including the screening, up to 28 days, baseline period, and treatment period of 90 days.
official title
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