TQD3606 is a fixed-dose combination of meropenem and avibatam. This study is a phase I clinical study to evaluate the safety, tolerability and pharmacokinetic characteristics of TQD3606 injection in a single center, randomized, double-blind, placebo-controlled, single and multiple administration in healthy subjects, and to explore the excretion of TQD3606 in urine. To evaluate the tolerability and safety of injectable TQD3606 after single and multiple dosing in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
56
TQD3606 is a fixed-dose combination of meropenem and avibatam.
Meropenem is a carbapenem antibiotic
Avibactam is beta-lactamase inhibitor.
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, China
Maximum Concentration (Cmax)
Maximum Concentration
Time frame: 1 hour before administration,to 24 hours after administration.
Area under the plasma concentration-time curve from initial dosing to 24 hours (AUC0-24)
Area under the plasma concentration-time curve from initial dosing to 24 hours
Time frame: 1 hour before administration,to 24 hours after administration.
Time to maximum concentration following drug administration (Tmax)
Time to maximum concentration following drug administration
Time frame: 1 hour before administration,to 24 hours after administration.
Apparent terminal elimination half-life following drug administration (t1/2)
Apparent terminal elimination half-life following drug administration
Time frame: 1 hour before administration,to 24 hours after administration.
Area under plasma concentration-time curve from first dosing to last measurable concentration point (AUC0-t)
Area under plasma concentration-time curve from first dosing to last measurable concentration point
Time frame: 1 hour before administration,to 24 hours after administration.
The amount of drug excreted through urine 24 hours after administration (Ae0-24)
The amount of drug excreted through urine 24 hours after administration
Time frame: 1 hour before administration,to 24 hours after administration.
Cumulative excretion rate of drugs through urine
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It is a placebo.
Cumulative excretion rate of drugs through urine
Time frame: 1 hour before administration,to 24 hours after administration.
The total clearance (CLt) The total clearance (CLt)
The total clearance
Time frame: 1 hour before administration,to 24 hours after administration.
Renal clearance (CLr)
Renal clearance
Time frame: 1 hour before administration,to 24 hours after administration.
Elimination rate constant(λz)
Elimination rate constant
Time frame: 1 hour before administration,to 24 hours after administration.
Apparent volume of distribution (Vd/F)
Apparent volume of distribution
Time frame: 1 hour before administration,to 24 hours after administration.
Mean residence time (MRT)
Mean residence time
Time frame: 1 hour before administration,to 24 hours after administration.
Valley concentration (Cmin,ss)
Valley concentration
Time frame: Within 60 minutes before 8th to 10th administration and 24 hours after 10th administration
Accumulation index
Accumulation index
Time frame: Within 60 minutes before 8th to 10th administration and 24 hours after 10th administration
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time frame: Baseline up to 24 hours after administration
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Monitor the safety indicators of subjects during the trial
Time frame: Baseline up to 24 hours after administration
Body temperature
Monitor the safety indicators of subjects during the trial
Time frame: 1 hour before administration and 24 hours after administration
Pulse
Monitor the safety indicators of subjects during the trial
Time frame: 1 hour before administration and 24 hours after administration
Systolic and diastolic blood pressure
Monitor the safety indicators of subjects during the trial
Time frame: 1 hour before administration and 24 hours after administration
Number of participants with abnormal laboratory test results
Monitor the safety indicators of subjects during the trial
Time frame: Baseline up to 24 hours after administration