Status: Recruiting
Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation
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.
Participants needed: 152
Trial details
Phase: Phase 1Age: 18-60Biological sex: AllType: InterventionalSponsor: Novartis PharmaceuticalsUpdated: Oct 5, 2026Locations: 6
Eligibility criteria
Healthy male and female (non-childbearing potential) participants between 18 and... [+1]
Participants with homozygous and heterozygous familial hypercholesterolemia will... [+1]