Safety and Efficacy of IBI306 in HeFH Patients

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Criteria

Inclusion Criteria:

• Subjects must meet all of the following inclusion criteria in order to be included in the study:

• Provide a signed and dated informed consent form;

• Men or women with an age of 18 to 70 years of age at screening (Inclusive);

• Weight ≥ 40 kg during screening

• heterozygous familial hypercholesterolemia patients

• Maintain a low-fat diet and stabilize the current lipid-lowering therapy.

Exclusion Criteria:

• Subjects who do not meet any of the following exclusion criteria cannot be included in the study:

• Patients diagnosed as homozygous familial hypercholesterolemia;

• Dialysis or plasmapheresis was performed within 4 months prior to screening;

• Patients who have undergone liver transplant surgery;

• Subjects adjusted for treatment of statins, ezetimibe, niacin, omega-fatty acids or doses within 4 weeks prior to screening;

• New York Heart Association (NYHA) grade III or IV heart failure, or recent detection of left ventricular ejection fraction ≤ 30%;

• Have serious cardiovascular, cerebrovascular, liver and kidney related diseases;