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There is one clinical trial.
This is a single center, double-blinded, placebo-controlled phase I clinical trail in healthy volunteer of meplazumab for injection. The primary objective of this phase I trial is to evaluate the safety, tolerability, pharmacokinetic characteristics and occupancy characteristics of peripheral blood cell receptors of meplazumab in healthy volunteer, and provide a reference for the dosage of meplazumab in phase II clinical trial.
Description: Nature, incidence, and severity of AEs/SAEs, and the relationship to meplazumab treatment.Measure: Incidence rate of treatment-related adverse events as assessed by CTCAE v5.0 Time: 0-28 days
Description: AUC0-tnMeasure: Pharmacokinetic assessments of meplazumab- AUC0-tn Time: 0-28 days
Description: AUC0-∞Measure: Pharmacokinetic assessments of meplazumab- AUC0-∞ Time: 0-28 days
Description: Maximum observed plasma concentration of meplazumab (Cmax)Measure: Pharmacokinetic assessments of meplazumab-Cmax Time: 0-28 days