SAD/MAD Safety and PK Study of QPX9003 (Novel Polymyxin) in Normal Healthy Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bacterial Infections
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: double-blind, placebo controlled ascending single and multiple doseMasking: Triple (Participant, Care Provider, Investigator)Masking Description: double-blind, placebo controlled ascending single- and multiple-dosePrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
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-res...
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
Tracking Information
- NCT #
- NCT04808414
- Collaborators
- Biomedical Advanced Research and Development Authority
- Investigators
- Study Director: Jeffery S Loutit, MBChB Qpex Biopharma, Inc.