Phase 1 Study of Oral QPX2015 in Healthy Adult Subjects

Phase 1 Completed 40 enrolled Qpex Biopharma, Inc. Biomedical Advanced Research and Development Authority · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

QPX2015 (beta-lactam antibiotic) is being studied at higher than approved doses to combine with a new beta-lactamase inhibitor to treat bacterial infections, including those due to multi-drug resistant bacteria.

Timeline

Start: 2019-05-20
Primary completion: 2019-10-06
Completion: 2019-10-06

Publications

Hernandez-Mitre MP, Wallis SC, Morgan EE, Dudley MN, Loutit JS, Griffith DC, Roberts JA. A phase I, randomized, double-blind, placebo-controlled, ascending single- and multiple-dose study of the pharmacokinetics, safety, and tolerability of oral ceftibuten in healthy adult subjects. Antimicrob Agents Chemother. 2024 Jan 10;68(1):e0109923. doi: 10.1128/aac.01099-23. Epub 2023 Dec 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	QPX2015	Unknown	400 mg	Oral
Subject	QPX2015	Unknown	600 mg	Oral
Subject	QPX2015	Unknown	800 mg	Oral

Phase 1 Study of Oral QPX2015 in Healthy Adult Subjects

Summary

Timeline

Publications

Drugs

Indications