This study is a first-in-human, Phase 1, randomized, double- blind, four-part, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of single (Part 1) and repeat (Part 2) escalating intravenous doses of KSP-1007. Repeated escalating doses of KSP-1007 will be co-administered with meropenem (Part 3) and single, ascending doses of KSP-1007 will be administered alone in healthy Japanese subjects (Part 4)
Carbapenem-resistant Gram-negative bacteria are responsible for serious, life-threatening infections and are regarded as an urgent threat by the Centers for Disease Control and Prevention and the World Health Organizations. One principal mechanism of carbapenem resistance is bacterial production of carbapenemases, which reduce the effectiveness of meropenem and other carbapenem class antibiotics. Sumitovant Biopharma is developing a fixed combination of meropenem and KSP-1007 for the treatment of serious bacterial infections.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
123
PRA Health Sciences
Lenexa, Kansas, United States
Incidence of adverse events assessed by subject .
Incidence of adverse events
Time frame: up to Day 14
Peak plasma concentration of KSP-1007
The plasma concentration of KSP-1007 will be measured over time, and the peak plasma concentration, or Cmax, of KSP-1007 will be determined
Time frame: Up to 5 days after dosing
Plasma concentration of KSP-1007 versus time curve
The plasma concentration of KSP-1007 will be measured over time and the area under the curve, or AUC, of KSP-1007 will be determined
Time frame: Up to 5 days after dosing
Cumulative amount of KSP-1007 excreted in urine over time
Total amount of unchanged drug excreted in urine over a dosing interval
Time frame: Up to 5 days after start of dosing
Renal clearance of KSP-1007 in urine over time
Renal clearance in urine. Urine was collected up to 5 days after dosing.
Time frame: Up to 5 days after start of dosing
Peak plasma concentration of meropenem
The plasma concentration of meropenem will be measured over time, and the peak plasma concentration, or Cmax, of meropenem will be determined
Time frame: Up to 5 days after start of dosing
Plasma concentration versus time curve of meropenem
The plasma concentration of meropenem will be measured over time and the area under the curve, or AUC, of meropenem will be determined
Time frame: Up to 5 days after start of dosing
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Cumulative amount of meropenem excreted in urine over time
Total amount of unchanged drug excreted in urine over a dosing interval.
Time frame: Up to 5 days after start of dosing
Renal clearance of meropenem in urine over time
Renal clearance in urine. Urine was collected up to 5 days after dosing.
Time frame: Up to 5 days after start of dosing
ECG QTcF interval
Change from baseline QTcF interval
Time frame: 24 hours after start of dosing