Hyperlipemia
Conditions
Brief summary
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.
Interventions
BIOLOGICALBiological：JS002
Administered by subcutaneous injection
BIOLOGICALPlacebo
Administered by subcutaneous injection
Sponsors
Shanghai Junshi Bioscience Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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%);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) to week 12 | 12 weeks after the first dose |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Absolute value change from baseline in low-density lipoprotein cholesterol (LDL-C) | Twelve weeks after the last dose |
Other
| Measure | Time frame |
|---|---|
| Change from baseline in proprotein convertase total / free pcsk9 | Twelve weeks after the last dose |
| Serum concentrations of JS002 | Twelve weeks after the last dose |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | Twelve weeks after the last dose |
Countries
China
Outcome results
None listed