VNRX-5024 Safety and PK in Healthy Adult Volunteers

Phase 1 Completed 36 enrolled Basilea Pharmaceutica National Institute of Allergy and Infectious Diseases (NIAID) · collab

RandomizedSequentialDouble-blindBasic science

Summary

This is a 2-part dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-5024. Subjects will be enrolled in one of three dose cohorts. They will receive a single dose on Day 1 in Part 1 and will proceed into the multiple dose Part 2 of the study after safety assessments and PK samples are collected. In the multiple dose part of the study, subjects will receive multiple doses of VNRX-5024 for 10 days.

Timeline

Start: 2020-07-27
Primary completion: 2020-12-31
Completion: 2020-12-31

Publications

Dorr MB, de Oliveira CF, van de Wetering J, Lowe K, Sabato P, Winchell G, Chen H, McGovern PC. Pharmacokinetics and safety of single and repeat doses of ceftibuten in healthy participants: a phase 1 dose escalation study. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0008725. doi: 10.1128/aac.00087-25. Epub 2025 Aug 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	VNRX-5024	Unknown	400 mg	Oral
Subject	VNRX-5024	Unknown	800 mg	Oral
Subject	VNRX-5024	Unknown	1200 mg	Oral

Indications

No indication recorded.