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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

NCT07626281

RecruitingPhase 1

Sponsor: Novartis Pharmaceuticals

Conditions: Inclisiran Formulation

Interventions: Inclisiran formulation containing PS80, Currently marketed inclisiran formulation

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (3)

Lenexa, Kansas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States