Name (Synonyms) | Correlation |
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Name (Synonyms) | Correlation | |
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D045169 | Severe Acute Respiratory Syndrome NIH | 0.05 |
D018352 | Coronavirus Infections NIH | 0.04 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
This is a randomized, double-blind, placebo-controlled, phase I clinical study to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of JS016 (anti-SARS-CoV-2 monoclonal antibody) injection in Chinese healthy subjects after intravenous infusion of single dose.Eligible patients will be injection JS016 (anti-SARS-CoV-2 monoclonal antibody)
Description: Any adverse event, serious adverse event (SAE) occurred during the clinical study, including clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs will be observed for all the subjects, the their clinical manifestations and features, severity, time to onset, end time, therapeutic measures and outcomes will be recorded, and the correlation of the adverse events with the investigational product will be judged
Measure: Correlation of adverse events with the investigational product Time: 12 WeeksDescription: Area under the curve from the time of dosing to the last measurable concentration time t (AUC0-last);
Measure: Primary pharmacokinetic variables Time: 12 WeeksDescription: Maximum concentration (Cmax);
Measure: Primary pharmacokinetic variables Time: 12 WeeksDescription: Mean residence time (MRT)
Measure: Primary pharmacokinetic variables Time: 12 WeeksDescription: Terminal half life (t1/2);
Measure: Primary pharmacokinetic variables Time: 12 WeeksDescription: Area under the analyte concentration-time curve from time 0 and extrapolated to infinite time (AUC0-∞);
Measure: pharmacokinetic Time: 12 WeeksDescription: Time to maximum concentration (Tmax);
Measure: pharmacokinetic Time: 12 WeeksDescription: Clearance (CL);
Measure: pharmacokinetic Time: 12 WeeksDescription: Apparent terminal elimination rate constant (λz)
Measure: pharmacokinetic Time: 12 WeeksDescription: Apparent volume of distribution (Vd)
Measure: pharmacokinetic Time: 12 Weeks