VNRX-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers

Summary

This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion in healthy subjects. In part 1, subjects will receive a single dose of VNRX-5133; in part 2 subjects will receive VNRX-5133 for 7 days.

Timeline

Start

2016-11

Primary completion

2017-06

Completion

2017-06

Publications

• Dowell JA, Dickerson D, Henkel T. Safety and Pharmacokinetics in Human Volunteers of Taniborbactam (VNRX-5133), a Novel Intravenous beta-Lactamase Inhibitor. Antimicrob Agents Chemother. 2021 Oct 18;65(11):e0105321. doi: 10.1128/AAC.01053-21. Epub 2021 Aug 9.

Drugs

Indications