SAD/MAD Safety and PK Study of QPX9003 (Novel Polymyxin) in Normal Healthy Volunteers
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

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
    

Intervention name(s): QPX9003 for IV Infusion; Placebo for IV infusion
Intervention type(s): Drug; Drug
Intervention description(s): antibiotic; Placebo comparator
Other intervention name(s): novel IV polymyxin antibiotic; IV saline
Intervention MeSH terms: Anti-Bacterial Agents; Polymyxins
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind, placebo controlled ascending single and multiple dose
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: polymyxin