NCT05072444

Drug-Drug Interaction Study of IV QPX2014 Combined With QPX7728 in Healthy Adult Subjects

A Phase 1, Randomized, Double-Blind, Single-Dose, Drug-Drug Interaction Study to Determine the Impact of Co-administration of QPX7728 on the Pharmacokinetics of QPX2014 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Qpex Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The Centers for Disease Control (CDC) has listed carbapenem-resistant Enterobacteriaceae and Acinetobacter as urgent threats and multidrug resistant Pseudomonas, and extended spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae as serious threats \[CDC, 2019\]. Consistent with the global nature of these resistant bacteria, the World Health Organization (WHO) has designated carbapenem-resistant, ESBL-producing Enterobacteriaceae, carbapenem-resistant Acinetobacter baumannii, and carbapenem-resistant Pseudomonas aeruginosa as pathogens for which new agents are critically needed \[WHO, 2017\]. Qpex Biopharma is developing a fixed combination antibiotic of QPX2014 plus an ultra-broad spectrum beta-lactamase inhibitor, QPX7728.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	QPX7728	beta lactamase inhibitor
DRUG	QPX2014	antibiotic

Timeline

• Start date: 2021-11-15
• Primary completion: 2021-11-23
• Completion: 2021-11-23
• First posted: 2021-10-11
• Last updated: 2022-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study