Overview

Safety and Efficacy of IBI306 in HeFH Patients

Status:
Active, not recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol(LDL-C)uptake. In phase I study IBI306 was shown to be safe and well tolerated. There was robust reduction in LDL-C, Apo(B), non-HDL-C and lipoprotein (a) in healthy subjects. This study is a randomized, double-blind, placebo-controlled, repeated-dosing, multiple ascending dose trial to evaluate the efficacy and safety of a novel PCSK-9 anti-body, IBI306, in Chinese patients with heterozygous familial hypercholesterolemia.
Phase:
Phase 3
Details
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.