NCT04808414

SAD/MAD Safety and PK Study of QPX9003 (Novel Polymyxin) in Normal Healthy Volunteers

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability and Pharmacokinetics of Intravenous (IV) QPX9003 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Qpex Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The worldwide spread of resistance to antibiotics among gram-negative bacteria, particularly members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of hospital acquired infections. In particular, the presence of multi-drug resistant Acinetobacter baumannii and Pseudomonas aeruginosa in hospitals around the world poses a considerable threat. .

Detailed description

The United States (US) Centers for Disease Control (CDC) have listed multidrug-resistant (MDR) Acinetobacter and MDR Pseudomonas aeruginosa as serious threats \[CDC, 2019\]. Consistent with the global nature of these resistant bacteria, the World Health Organization (WHO) has designated carbapenem-resistant Acinetobacter baumannii, and carbapenem resistant Pseudomonas aeruginosa as critical threats \[WHO, 2017\]. To combat these serious threats Qpex has developed QPX9003, a next generation polymyxin that is more potent than existing polymyxins against P. aeruginosa and A. baumannii and has exhibited less nephrotoxicity in preclinical studies. There remains a significant unmet need for new IV agents to treat gram-negative infections due to resistant bacteria in hospital settings. Some progress has been made in the successful development of new agents to address drug-resistant infections, particularly IV agents for resistant gram-negative bacteria \[Talbot et al, 2019\]. While some of these agents have addressed urgent threats like carbapenem-resistant Enterobacteriaceae (CRE), their activity is largely confined to strains producing serine carbapenemases; none of these agents have reliable activity against metallo beta-lactamase producing CRE. Moreover, none of these recently approved agents have activity against carbapenem-resistant Acinetobacter baumannii \[Talbot et al, 2019\]. The increasing prevalence of multidrug-resistant gram-negative bacteria, in particular carbapenemase producing Enterobacteriaceae, A. baumannii, and P. aeruginosa, has resulted in an increase in the use of polymyxin antibiotics as salvage therapy \[Biswas et al. 2017\]. This Phase 1 study will assess the safety, tolerability and pharmacokinetics of single and multiple IV administered ascending doses (SAD/MAD) of IV QPX9003 in healthy adult subjects. Qpex is developing IV QPX9003 which is a next generation polymyxin with activity against multi-drug resistant A. baumannii and P. aeruginosa

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	QPX9003 for IV Infusion	antibiotic
DRUG	Placebo for IV infusion	Placebo comparator

Timeline

• Start date: 2021-06-03
• Primary completion: 2022-07-14
• Completion: 2022-07-14
• First posted: 2021-03-22
• Last updated: 2022-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study