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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single-dose of JS401 in healthy volunteers with normal or mildly elevated triglycerides.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: JS401 injection | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS401 | Drug | Single dose of JS401 by subcutaneous (sc) injections |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Number of Participants with Adverse Events (AEs) | Up to 112 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Peak Plasma Concentration of JS401 | Up to 48 hours post-dose |
| Time to Maximum Plasma Concentration (Tmax) | Time to Maximum Plasma Concentration of JS401 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fugui Wang | Contact | 8613511074153 | fugui_wang@junshipharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | 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 |
| Drug |
Calculated volume to match active treatment |
|
| Up to 48 hours post-dose |
| Terminal Elimination Half-Life (t1/2) | Terminal Elimination Half-Life (t1/2) of JS401 | Up to 48 hours post-dose |
| Area Under the Plasma Concentration Versus Time Curve (AUC) | Area Under the Plasma Concentration Versus Time Curve of JS401 | Up to 48 hours post-dose |
| Angiopoietin-like 3 (ANGPTL3) | Reduction in Fasting Serum ANGPTL3 from Pre-Dose Baseline | Up to 112 days post-dose |
| Triglycerides | Reduction in Fasting Serum LDL-C from Pre-Dose Baseline | Up to 112 days post-dose |
| immunogenic characteristics ADA of JS401 | The number and percentage of subjects who were positive for anti-JS401 anti-drug antibody (ADA) after administration of JS401 injection were counted, and the titer of ADA-positive samples was analyzed. | Up to 112 days post-dose |
| Low-density lipoprotein cholesterol (LDL-C) | Reduction in Fasting Serum LDL-C from Pre-Dose Baseline | Up to 112 days post-dose |
| Non-high-density lipoprotein cholesterol (non-HDL-C) | Reduction in Fasting Serum non-HDL-C from Pre-Dose Baseline | Up to 112 days post-dose |
| Very low-density lipoprotein cholesterol (VLDL-C) | Reduction in Fasting Serum VLDL-C from Pre-Dose Baseline | Up to 112 days post-dose |
| High-density lipoprotein cholesterol (HDL-C) | Reduction in Fasting SerumHDL-C from Pre-Dose Baseline | Up to 112 days post-dose |
| Lipoprotein (a) (Lp(a)) | Reduction in Fasting Lp(a) from Pre-Dose Baseline | Up to 112 days post-dose |
| Apolipoprotein B (ApoB) | Reduction in Fasting ApoB from Pre-Dose Baseline | Up to 112 days post-dose |
| Apolipoprotein A1 (ApoA1) | Reduction in Fasting ApoA1 from Pre-Dose Baseline | Up to 112 days post-dose |
| Q-T interval | Change in QTc from baseline | Up to 112 days post-dose |