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Recruiting NCT07626281

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

Conditions: Inclisiran Formulation

Sex: All

Ages: 18 Years – 60 Years

Healthy volunteers: Yes

Phase: PHASE1

Enrollment: 120

Sponsor: Novartis Pharmaceuticals

Location: Lenexa Research Unit Lenexa Kansas

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.

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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07626281). StuddyBuddy aggregates publicly available trial information.