A Pharmacokinetic Study of Polymyxin B in Healthy Subjects and Subjects With Renal Insufficiency

Inclusion Criteria: * Male and female subjects between 20 and 70 years of age (inclusive) at screening. * Subjects with Body Mass Index (BMI) between 18.5 and 35 kg/m² (inclusive) at screening. * Subjects with sitting heart rate between 60 and 100 beats/min at screening. * Subjects with serum albumin between 3.5 and 5.7 g/dL (inclusive). * Subjects (normal renal function group) with creatinine clearance (CLcr) ≥ 90 mL/min at screening; Subjects (mild renal insufficiency group) with CLcr between 60 and 89 mL/min (inclusive) within 3 months prior to screening and at screening; Subjects (long-term IHD group) with ESRD receiving IHD therapy 3 times a week for at least 3 months prior to dosing of study drug. * Female subjects with childbearing potential must have a negative serum pregnancy test at screening and pregnancy test on Day -1. * Subjects with sufficient peripheral vascular access for blood collection. * Subject is willing and able to comply with all study procedures and restrictions. * Subject understands the study procedures and is willing and able to provide written informed consent. Exclusion Criteria: * Arm 1 (normal renal function group): Subject with history or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, psychiatric disease or disorder, with active bleeding or with head injury or meningitis 3 months prior to dosing, in the opinion of the i…