A Single Ascending Dose Study of AV-006 in Healthy Subjects

Status Not yet recruiting

Clinical Trial Summary

Characterization of the single dose pharmacokinetics of AV-006 in healthy male and female subjects. Description of safety and tolerability of AV-006 in healthy subjects

Clinical Trial Description

The present study is a first in human study of an avibactam prodrug to be administered orally. Avibactam is the β-lactamase inhibitor (BLI) component of the intravenous antibiotic AVYCAZQR (ceftazidime avibactam), approved in the US in 2015 to treat resistant Gram-negative infections. Avibactam is a non-β-lactam BLI without intrinsic antibacterial activity. Avibactam binds covalently with bacterial β-lactamases thereby preventing hydrolysis and inactivation of the partner β-lactam antibiotic.

Arixa and others have shown that that avibactam (the product of AV-006) restores the susceptibility of many oral β-lactam antibiotics against broad panels of clinical Enterobacteriaceae isolates that produce β-lactamases. ;

Study Design

Related Conditions & MeSH terms

Bacterial Infections

Clinical Trial Details

NCT number	NCT03931876
Study type	Interventional
Source	Arixa Pharmaceuticals
Contact	Julie Pribyl, BA
Phone	9196960350
Email	jpribyl@pharmadirections.com
Status	Not yet recruiting
Phase	Phase 1
Start date	June 24, 2019
Completion date	November 1, 2019

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