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JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JS002 | Experimental | Participants received one of 3 dose regimens of JS002 administered as multiple subcutaneous doses. |
|
| Placebo | Placebo Comparator | Participants received matching placebo dose regimens by subcutaneous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological:JS002 | Biological | Administered by subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) to week 12 | 12 weeks after the first dose |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | Twelve weeks after the last dose | |
| Serum concentrations of JS002 | Twelve weeks after the last dose | |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital Chinese Academy of Medical Sciences | Beijing | China |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo |
| Biological |
Administered by subcutaneous injection |
|
| 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 |
| Change from baseline in proprotein convertase total / free pcsk9 |
| Twelve weeks after the last dose |