VNRX-7145 SAD/MAD Safety and PK in Healthy Adult Volunteers

Phase 1 Completed 83 enrolled Basilea Pharmaceutica National Institute of Allergy and Infectious Diseases (NIAID) · collab

RandomizedSingle-groupDouble-blindBasic science

Summary

This is a 2-part, first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-7145. In part 1, subjects will receive a single dose of VNRX-7145; in part 2 subjects will receive multiple doses of VNRX-7145 for 10 days.

Timeline

Start: 2020-01-20
Primary completion: 2021-04-05
Completion: 2021-04-05

Publications

de Oliveira CF, Dorr MB, van de Wetering J, Lowe K, Sabato P, Winchell G, Chen H, McGovern PC. Safety and pharmacokinetics of single and multiple doses of ledaborbactam etzadroxil with or without ceftibuten in healthy volunteers. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0021025. doi: 10.1128/aac.00210-25. Epub 2025 Aug 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ledaborbactam etzadroxil	Small molecule	—	Oral

Indications

No indication recorded.