The study will enroll approximately 24 adult subjects in the following three Arms based on renal function. Approximately 8 subjects for each Arm are planned to be enrolled to fulfill the analysis of at least 6 evaluable subjects in each Arm. The subject who drops out of the study may be replaced at the discretion of the Sponsor.~Arm 1 (normal renal function group): Subjects with CLcr ≥ 90 mL/min~Arm 2 (mild renal insufficiency group): Subjects with CLcr between 60 and 89 mL/min (inclusive)~Arm 3 (long-term IHD group): Subjects with ESRD receiving IHD therapy 3 times a week for at least 3 months prior to dosing of study drug; Subjects will receive a single dose of polymyxin B one day after his/her 3rd dialysis of the week.
This is an open-label, single-center, single-dose, parallel-group study to evaluate the PK and safety profiles of polymyxin B administered by IV infusion in healthy subjects and subjects with renal insufficiency.