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
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
- 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