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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous RPX2014 and RPX7009 Alone and in Combination in Healthy Adult Subjects

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Trial Profile

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous RPX2014 and RPX7009 Alone and in Combination in Healthy Adult Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 15 Jun 2021

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At a glance

  • Drugs Meropenem/vaborbactam (Primary) ; Meropenem; Vaborbactam
  • Indications Bacteraemia; Bacterial infections; Gram-negative infections; Intra-abdominal infections; Nosocomial pneumonia; Pneumonia; Pyelonephritis; Urinary tract infections
  • Focus Adverse reactions
  • Sponsors Rempex Pharmaceuticals

    • Most Recent Events

    • 07 Jun 2021 Results of a population pharmacokinetic analysis using pooled data from two Phase 1 (Rempex501 & Rempex504) and two Phase 3 studies ( TANGO 1 & TANGO 2) published in the Antimicrobial Agents and Chemotherapy
    • 05 Feb 2018 Results assessing tolerability and pharmacokinetics of meropenem, RPX 7009 and the combination meropenem/RPX 7009 in healthy adult volunteers, were published in the Antimicrobial Agents and Chemotherapy.
    • 04 Dec 2013 Status changed from recruiting to completed, according to a Medicines Company media release.
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