Hyperlipidemia Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Kinetic Effects in Healthy Volunteers With Normal or Mildly Elevated Triglycerides
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.
Status | Recruiting |
Enrollment | 44 |
Est. completion date | September 21, 2024 |
Est. primary completion date | June 29, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: 1. Healthy male or female subjects aged 18~60 (inclusive) at the time of signing the ICF, with no less than 1/3 of either gender; 2. Fasting TG=1.1mmol/L (100 mg/dL) and = 5.0mmol/L (450mg/dL) at screening; (3) Fasting LDL-C at screening> 1.8 mmol/L (70 mg/dL). Exclusion Criteria: 1. Have a medical history or clinical evidence that the subject has obvious concomitant diseases (including but not limited to: cardiovascular, respiratory, digestive, urinary, neurological, blood, immunological, endocrine and metabolic, infection, etc.), or any clinically significant abnormalities found in physical examination, laboratory examination, and ECG examination, which are judged by the investigator to not meet the standards of clinical health or are not suitable for participating in clinical trials; 2. Acute or chronic infection requiring hospitalization or undergoing systemic parenteral therapy (antiviral/bacterial/fungal/parasitic, etc.) within 60 days prior to randomization; 3. Positive for syphilis antibodies, or positive for human immunodeficiency virus (HIV) antibodies, or positive for hepatitis C virus (HCV) antibodies, or positive for hepatitis B virus surface antigen (HBsAg) at screening; 4. History of substance abuse within 12 months prior to screening, or positive urine drug screening at screening; 5. History of alcohol dependence within 6 months prior to screening, or positive breath test for alcohol at screening |
Country | Name | City | State |
---|---|---|---|
China | Peking University Third Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Shanghai Junshi Bioscience Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Adverse Events (AEs) | Number of Participants with Adverse Events (AEs) | Up to 112 days post-dose | |
Secondary | Peak Plasma Concentration (Cmax) | Peak Plasma Concentration of JS401 | Up to 48 hours post-dose | |
Secondary | Time to Maximum Plasma Concentration (Tmax) | Time to Maximum Plasma Concentration of JS401 | Up to 48 hours post-dose | |
Secondary | Terminal Elimination Half-Life (t1/2) | Terminal Elimination Half-Life (t1/2) of JS401 | Up to 48 hours post-dose | |
Secondary | 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 | |
Secondary | Angiopoietin-like 3 (ANGPTL3) | Reduction in Fasting Serum ANGPTL3 from Pre-Dose Baseline | Up to 112 days post-dose | |
Secondary | Triglycerides | Reduction in Fasting Serum LDL-C from Pre-Dose Baseline | Up to 112 days post-dose | |
Secondary | 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 | |
Secondary | Low-density lipoprotein cholesterol (LDL-C) | Reduction in Fasting Serum LDL-C from Pre-Dose Baseline | Up to 112 days post-dose | |
Secondary | 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 | |
Secondary | Very low-density lipoprotein cholesterol (VLDL-C) | Reduction in Fasting Serum VLDL-C from Pre-Dose Baseline | Up to 112 days post-dose | |
Secondary | High-density lipoprotein cholesterol (HDL-C) | Reduction in Fasting SerumHDL-C from Pre-Dose Baseline | Up to 112 days post-dose | |
Secondary | Lipoprotein (a) (Lp(a)) | Reduction in Fasting Lp(a) from Pre-Dose Baseline | Up to 112 days post-dose | |
Secondary | Apolipoprotein B (ApoB) | Reduction in Fasting ApoB from Pre-Dose Baseline | Up to 112 days post-dose | |
Secondary | Apolipoprotein A1 (ApoA1) | Reduction in Fasting ApoA1 from Pre-Dose Baseline | Up to 112 days post-dose | |
Secondary | Q-T interval | Change in QTc from baseline | Up to 112 days post-dose |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00001154 -
Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
|
||
Completed |
NCT02927184 -
Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
|
Phase 2 | |
Completed |
NCT04640012 -
Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DC371739 Single-Dose Treatment in Healthy Subjects
|
Phase 1 | |
Completed |
NCT03213288 -
Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status
|
N/A | |
Completed |
NCT00382564 -
Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease
|
N/A | |
Recruiting |
NCT02979704 -
A Comparative Study of Rosuvastatin and Atorvastatin in Patients With Hyperlipidemia
|
Phase 2/Phase 3 | |
Completed |
NCT02569814 -
A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin
|
Phase 1 | |
Completed |
NCT02280590 -
Comparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia
|
Phase 4 | |
Completed |
NCT02428998 -
Safety for 24 Weeks Intake of Korean Red Ginseng in Adults
|
N/A | |
Completed |
NCT01678183 -
Financial Incentives for Medication Adherence
|
N/A | |
Completed |
NCT01694446 -
Regulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose
|
N/A | |
Completed |
NCT01426412 -
A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol
|
Phase 1 | |
Completed |
NCT01131832 -
Genetic Basis for Heterogeneity in Response of Plasma Lipids to Plant Sterols
|
Phase 4 | |
Completed |
NCT00534105 -
Lipid Metabolism in Gestational Diabetes
|
N/A | |
Completed |
NCT00758303 -
A Study to Evaluate the Lipid Regulating Effects of TRIA-662
|
Phase 2/Phase 3 | |
Recruiting |
NCT00408824 -
Investigation of Genetic Risk of Metabolic Syndrome in Company Employee (NGK Study)
|
N/A | |
Completed |
NCT00362206 -
Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin
|
Phase 3 | |
Terminated |
NCT00299169 -
Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes
|
Phase 4 | |
Completed |
NCT00414986 -
Using Learning Teams for Reflective Adaptation for Diabetes and Depression
|
N/A | |
Completed |
NCT00381992 -
Risk Assessment of Long-Haul Truck Drivers
|
N/A |