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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
44
Peking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGNumber of Participants with Adverse Events (AEs)
Number of Participants with Adverse Events (AEs)
Time frame: Up to 112 days post-dose
Peak Plasma Concentration (Cmax)
Peak Plasma Concentration of JS401
Time frame: Up to 48 hours post-dose
Time to Maximum Plasma Concentration (Tmax)
Time to Maximum Plasma Concentration of JS401
Time frame: Up to 48 hours post-dose
Terminal Elimination Half-Life (t1/2)
Terminal Elimination Half-Life (t1/2) of JS401
Time frame: 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
Time frame: Up to 48 hours post-dose
Angiopoietin-like 3 (ANGPTL3)
Reduction in Fasting Serum ANGPTL3 from Pre-Dose Baseline
Time frame: Up to 112 days post-dose
Triglycerides
Reduction in Fasting Serum LDL-C from Pre-Dose Baseline
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 112 days post-dose
Low-density lipoprotein cholesterol (LDL-C)
Reduction in Fasting Serum LDL-C from Pre-Dose Baseline
Time frame: 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
Time frame: Up to 112 days post-dose
Very low-density lipoprotein cholesterol (VLDL-C)
Reduction in Fasting Serum VLDL-C from Pre-Dose Baseline
Time frame: Up to 112 days post-dose
High-density lipoprotein cholesterol (HDL-C)
Reduction in Fasting SerumHDL-C from Pre-Dose Baseline
Time frame: Up to 112 days post-dose
Lipoprotein (a) (Lp(a))
Reduction in Fasting Lp(a) from Pre-Dose Baseline
Time frame: Up to 112 days post-dose
Apolipoprotein B (ApoB)
Reduction in Fasting ApoB from Pre-Dose Baseline
Time frame: Up to 112 days post-dose
Apolipoprotein A1 (ApoA1)
Reduction in Fasting ApoA1 from Pre-Dose Baseline
Time frame: Up to 112 days post-dose
Q-T interval
Change in QTc from baseline
Time frame: Up to 112 days post-dose