Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06041165
Other study ID # JS401-001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date August 31, 2023
Est. completion date September 21, 2024

Study information

Verified date September 2023
Source Shanghai Junshi Bioscience Co., Ltd.
Contact Fugui Wang
Phone 8613511074153
Email fugui_wang@junshipharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
JS401
Single dose of JS401 by subcutaneous (sc) injections
Placebo
Calculated volume to match active treatment

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Junshi Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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
See also
  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