NCT03931876

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

A Placebo Controlled, Double Blind, Single Ascending Dose Study of AV-006 in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Arixa Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	Placebos	Single ascending dose administration
DRUG	AV-006	Single ascending dose administration

Timeline

• Start date: 2019-06-24
• Primary completion: 2019-09-01
• Completion: 2019-11-01
• First posted: 2019-04-30
• Last updated: 2019-05-01

Locations

1 site across 1 country: Australia