A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of Intravenous WCK 5222 (Zidebactam and Cefepime) in Healthy Adult Human Subjects

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of Intravenous WCK 5222 (Zidebactam and Cefepime) in Healthy Adult Human Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 03 Apr 2017

At a glance

  • Drugs Cefepime/zidebactam (Primary)
  • Indications Gram-negative infections
  • Focus Adverse reactions
  • Sponsors Wockhardt
  • Most Recent Events

    • 03 Apr 2017 According to a Wockhardt media release, the US FDA has agreed to an abridged phase III trial of WCK-5222 based on evaluation of preclinical and clinical data from this trial.
    • 11 May 2016 Status changed from recruiting to completed.
    • 18 Mar 2016 New trial record
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