NCT03815812

Multiple Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Chinese Patients With Hypercholesterolemia

A Randomized, Double-blind, Placebo-controlled, Repeated-dosing, Multiple Ascending Dose Trial to Evaluate the Safety and Tolerability of a Novel PCSK-9 Anti-body, IBI306, in Chinese Patients With Hypercholesterolemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 safety and tolerability of a novel PCSK-9 anti-body, IBI306, in Chinese patients with hypercholesterolemia.

Detailed description

A total of 60 patients who meet the criteria for admission and have a clinical diagnosis of hypercholesterolemia and have received statin for at least 4 weeks will be randomized and receive different dose groups of IBI306 or matching placebo. Ascending dose design includes 6 dose levels: 75 mg Q2W, 140 mgQ2W, 300 mg Q4W，420mg Q4W, 450 mg Q6W，and 600 mg Q6W. Total duration of the study per subject is 12 weeks.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	IBI306	Cohort 1: 75mg Q2W Cohort 2: 140mg Q2W Cohort 3: 300mg Q4W Cohort 4: 420mg Q4W Cohort 5: 450mg Q6W Cohort 6: 600mg Q6W
DRUG	placebo	Cohort 1: 75mg Q2W Cohort 2: 140mg Q2W Cohort 3: 300mg Q4W Cohort 4: 420mg Q4W Cohort 5: 450mg Q6W Cohort 6: 600mg Q6W

Timeline

• Start date: 2019-03-07
• Primary completion: 2019-12-25
• Completion: 2019-12-25
• First posted: 2019-01-24
• Last updated: 2023-11-18

Locations

1 site across 1 country: China