A Study to Evaluate the Safety, Tolerability and Efficacy of Multiple Doses of JS002 in Patients With Hyperlipidemia..

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Efficacy, as Well as Immunogenecity, Pharmacokineticks and Pharmacodynamics of Multiple Doses of JS002 on Stable Statin Therapy in Patients With Hyperlipidemia.

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.

Inclusion Criteria:

1. Signed informed consent.
2. Age ≥18 and ≤65 years old;
3. Body mass index (BMI) ≥18 and ≤ 30 kg/m2;
4. Subjects who are receiving statin therapy at the time of screening or who are eligible for statin therapy can receive a stable dose of statin therapy for more than 28 days before randomization and are willing to maintain stable statin therapy during the study;
5. Low-density lipoprotein cholesterol (LDL-C) level ≥2.6mmol/L for subjects who are receiving statin and/or other lipid-lowering therapy at the time of screening, or LDL-C≥ 4.1mmol/L for subjects who didn't receive any-lowering therapy at the time of screening, and LDL-C still ≥2.6mmol/L before randomization;
6. Fasting triglycerides ≤4.5 mmol/L;

Exclusion Criteria:

1. Diagnosis of homozygous familial hypercholesterolemia;
2. History of New York heart association (NYHA) defined Ⅱ - Ⅳ heart failure;
3. History of uncontrolled arrhythmiast;
4. History of myocardial infarction, history of PTCA or PCI or CABG, history of unstable angina befor 90 days of randomization;
5. History of stroke or TIA；
6. Uncontrolled hypertension with SBP≥160mmHg and/or DBP≥100mmHg
7. Type 1 diabetes, or type 2 diabetes that is or poorly controlled（HbA1c> 8.0%);