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Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation

RecruitingPhase 1Ages 18 Years - 60 YearsAllNovartis Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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. Other protocol inclusion/exclusion criteria may apply
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What it tests

  • Inclisiran formulation containing PS80
  • Currently marketed inclisiran formulation
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Where

6 sites
ICON Early Clin Services Lenexa
Lenexa, United States
Lenexa Research Unit
Lenexa, United States
ICON Early Clin Service San Antonio
San Antonio, United States
Cardiovasular Renal Metabolism
San Antonio, United States
ICON Early Clinical Services SLC
Salt Lake City, United States
Salt Lake City Research Unit
Salt Lake City, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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