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

Antibiotic Toxicity Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Antibiotic Toxicity
• Renal Insufficiency

• NCT number: NCT05359627
• Study type: Interventional
• Source: TTY Biopharm
• Status: Completed
• Phase: Phase 1
• Start date: July 26, 2022
• Completion date: March 3, 2023