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

Study Overview
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Brief Summary
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JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.

Official Title
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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.

Conditions
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Hyperlipemia

Intervention / Treatment
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* Biological: Biological：JS002
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent. Age ≥18 and ≤65 years old; Body mass index (BMI) ≥18 and ≤ 30 kg/m2; 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; 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; Fasting triglycerides ≤4.5 mmol/L; Exclusion Criteria: Diagnosis of homozygous familial hypercholesterolemia; History of New York heart association (NYHA) defined Ⅱ - Ⅳ heart failure; History of uncontrolled arrhythmiast; History of myocardial infarction, history of PTCA or PCI or CABG, history of unstable angina befor 90 days of randomization; History of stroke or TIA； Uncontrolled hypertension with SBP≥160mmHg and/or DBP≥100mmHg Type 1 diabetes, or type 2 diabetes that is or poorly controlled（HbA1c> 8.0%);

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JS002<br>Participants received one of 3 dose regimens of JS002 administered as multiple subcutaneous doses. | Biological: Biological：JS002<br>* Administered by subcutaneous injection<br>|
| Placebo Comparator: Placebo<br>Participants received matching placebo dose regimens by subcutaneous injection. | Biological: Placebo<br>* Administered by subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) to week 12 |  | 12 weeks after the first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute value change from baseline in low-density lipoprotein cholesterol (LDL-C) |  | Twelve weeks after the last dose | 
| Percent change from baseline in Total Cholesterol(TC、HDL-C、non-HDL-C、VLDL-C、Apo B、Apo A1、Lp(a) and TG ) |  | Twelve weeks after the last dose | 
| Percentage change from baseline TC/HDL-C ratio |  | Twelve weeks after the last dose | 
| Percent change from baseline in Apolipoprotein B (Apo B) |  | Twelve weeks after the last dose | 
| Percent change from baseline in Apolipoprotein A-I (ApoA-I) |  | Twelve weeks after the last dose |