A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care.
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Number of Subjects With One or More Adverse Events (AEs) During the Treatment Period
Timeframe: 7 days
Number of Subjects With One or More Serious Adverse Events (SAEs)
Timeframe: 28 days
Alanine Aminotransferase (ALT)
Timeframe: Screening and Day 7
Aspartate Aminotransferase (AST)
Timeframe: Screening and Day 7
Alkaline Phosphatase (ALP)
Timeframe: Screening and Day 7
Total Bilirubin (Tbili)
Timeframe: Screening and Day 7
Serum Creatinine (sCr)
Timeframe: Screening and Day 7
Albumin (Alb)
Timeframe: Screening and Day 7
Hemoglobin (Hgb)
Timeframe: Screening and Day 7
Total White Blood Cell (WBC) Count
Timeframe: Screening and Day 7
Platelet (PLT) Count
Timeframe: Screening and Day 7
International Normalized Ratio (INR)
Timeframe: Screening and Day 7
QT Interval With Fridericia's Correction (QTcF)
Timeframe: Pre-dose and up to 24 hours post-dose
Categorical Change in QTcF
Timeframe: Pre-dose and up to 24 hours post-dose
Area Under the Plasma Concentration Versus Time Curve (AUC)
Timeframe: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Maximum Plasma Concentration (Cmax)
Timeframe: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Apparent Terminal Plasma Half-life (T1/2)
Timeframe: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Clearance (CL)
Timeframe: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Apparent Volume of Distribution Under Steady State Conditions (Vss)
Timeframe: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.