The Safety and Efficacy of Multiple-dose of JS002 in Subject With Hyperlipidemia
Status:
Recruiting
Trial end date:
2023-02-01
Target enrollment:
Participant gender:
Summary
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized,
double-blind, placebo-controlled study to evaluate the safety and efficacy, as well as
immunogenicity of JS002 treated repeatedly in patients with hyperlipidemia when combined with
statin therapy.
In this study, two dose group (150 mg, 300 mg) were set up in this study. 750 subjects are
plan to be enrolled (the study drug will be assigned to a 2:1 ratio of JS002 or placebo).
Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks
of follow-up.