Safety, pharmacokinetics and pharmacodynamics of Plozasiran in Chinese healthy volunteers.

ABSTRACT:

Background

Plozasiran (VSA001, ARO-APOC3) is an RNA interference therapy that targets Apolipoprotein C3 (APOC3), a key regulator of lipoprotein metabolism. The study aimed at assessing the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of plozasiran in Chinese healthy volunteers (HVs).

Methods

In this double-blind, placebo-controlled, phase I clinical study, a total of 24 Chinese adult HVs received single subcutaneous (SC) injection of 25 mg, 50 mg plozasiran or placebo on day 1. Safety, tolerability, PK and PD profiles were accessed during a follow-up period of 85 days.

Results

Eighteen HVs received plozasiran (25 mg: n = 9; 50 mg: n = 9) and 6 HVs received placebo. Plozasiran was well tolerated in Chinese HVs. No death, no severe adve

SUBMITTER: Wang F 

PROVIDER: S-EPMC12523034 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature