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JS016 (anti-SARS-CoV-2 monoclonal antibody)Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (0)


Name (Synonyms) Correlation

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 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

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)

NCT04441918 COVID-19; and High Infection Risk of SARS-CoV-2 Combination Product: JS016 (anti-SARS-CoV-2 monoclonal antibody)

Primary Outcomes

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 Weeks

Secondary Outcomes

Description: Area under the curve from the time of dosing to the last measurable concentration time t (AUC0-last);

Measure: Primary pharmacokinetic variables

Time: 12 Weeks

Description: Maximum concentration (Cmax);

Measure: Primary pharmacokinetic variables

Time: 12 Weeks

Description: Mean residence time (MRT)

Measure: Primary pharmacokinetic variables

Time: 12 Weeks

Description: Terminal half life (t1/2);

Measure: Primary pharmacokinetic variables

Time: 12 Weeks

Other Outcomes

Description: Area under the analyte concentration-time curve from time 0 and extrapolated to infinite time (AUC0-∞);

Measure: pharmacokinetic

Time: 12 Weeks

Description: Time to maximum concentration (Tmax);

Measure: pharmacokinetic

Time: 12 Weeks

Description: Clearance (CL);

Measure: pharmacokinetic

Time: 12 Weeks

Description: Apparent terminal elimination rate constant (λz)

Measure: pharmacokinetic

Time: 12 Weeks

Description: Apparent volume of distribution (Vd)

Measure: pharmacokinetic

Time: 12 Weeks


No related HPO nodes (Using clinical trials)