Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects

Phase 1 Completed 30 enrolled Venatorx Pharmaceuticals, Inc.

NaSingle-groupOpen-labelBasic science

Summary

This is a single-center, open-label study to assess the safety and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult male and female subjects. Thirty subjects will receive a total of 6 doses of cefepime-taniborbactam (2 g cefepime/0.5g taniborbactam) administered intravenously every 8 hours. Following the sixth dose of cefepime-taniborbactam, subjects will be assigned to one of six bronchoscopy sampling times.

Timeline

Start: 2021-06-29
Primary completion: 2021-09-27
Completion: 2021-09-27

Publications

Rodvold KA, Gotfried MH, Sabato P, Henkel T, McGovern PC. Plasma and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult participants. Antimicrob Agents Chemother. 2025 Jul 2;69(7):e0049325. doi: 10.1128/aac.00493-25. Epub 2025 Jun 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cefepime	Small molecule	2 g	Intravenous
Subject	taniborbactam	Other / unclassified	0.5 g	Intravenous

Indications

No indication recorded.