Drug-Drug Interaction Study of IV QPX2014 Combined With QPX7728 in Healthy Adult Subjects - Trial NCT05072444
Access comprehensive clinical trial information for NCT05072444 through Pure Global AI's free database. This Phase 1 trial is sponsored by Qpex Biopharma, Inc. and is currently Completed. The study focuses on Bacterial Infections. Target enrollment is 12 participants.
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Study Focus
Sponsor & Location
Qpex Biopharma, Inc.
Timeline & Enrollment
Phase 1
Nov 15, 2021
Nov 23, 2021
Primary Outcome
Area under the plasma concentration versus time curve (AUC) between dosing groups,Peak plasma Concentration measurements by subject and by dosing group,Urine Pharmacokinetic (PK) amount excreted by subject and by dosing group,Urine PK % dose excreted by subject and by dosing group,Incidence of Treatment -Emergent Adverse events (AEs) by subject and by dosing group,Number of patients with changes from baseline in safety parameters
Summary
QPX7728 is an ultra-broad-spectrum beta-lactamase inhibitor, with activity against numerous
 beta-lactamases, including class A extended spectrum betalactamases (ESBLs), class C
 cephalosporinases, and extended spectrum class D oxacillinases (OXA) that can hydrolyze
 cephalosporins and can be found in Enterobacteriaceae and Pseudomonas aeruginosa (P.
 aeruginosa). QPX7728 is also a potent inhibitor of carbapenemases from all molecular classes,
 such as class A Klebsiella pheumoniae carbapenemase (KPC), class B New-Dehli
 Metalo-beta-lactamase (NDM) and Verona integron-encoded metallo-betalactamase (VIM), and
 class D OXA-48 that are found in carbapenem resistant Enterobacteriaceae, and also class D
 carbapenemases such as OXA-23 that are found in carbapenem resistant Acinetobacter baumannii.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05072444
Non-Device Trial