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

Phase 1 Completed 22 enrolled TTY Biopharm

Non-randomizedParallel-groupOpen-labelOther

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.

Timeline

Start: 2022-07-26
Primary completion: 2023-03-03
Completion: 2023-03-03

Publications

Fang YW, Huang CH, Jang TN, Lin SS, Wang JT, Huang YT, Tsai MH. Pharmacokinetic study of polymyxin B in healthy subjects and subjects with renal insufficiency. Clin Transl Sci. 2024 Dec;17(12):e70110. doi: 10.1111/cts.70110.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Polymyxin B	Peptide	0.75 mg/kg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications