MED Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous WCK 5222 (Zidebactam and Cefepime) in Healthy Volunteers
Completed · Phase 1 · Has a placebo group
Conditions studied: Serious Gram-negative Infections
In brief
Study to evaluate the safety, tolerability and pharmacokinetics of multiple escalating doses of intravenous WCK 5222 (Zidebactam and Cefepime) in healthy adult human subjects.
Key facts
- Study ID
- NCT02707107
- Run by
- Wockhardt
- People needed
- 20
- Starts
- 2016-03-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2016-08-04
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Have a body mass index of 18 to 30 kg/m2 (both inclusive) calculated as weight (kg)/height(m2).
- Resting supine blood pressure of 90 to 139 (systolic)/40 to 89 (diastolic) mmHg and a resting pulse rate of 40 to 100 beats per minute.
- Calculated creatinine clearance ≥80 mL/min (Cockcroft-Gault method).
- All values of hematology, serum chemistry, coagulation, and urinalysis showing no clinically significant deviations from normal as judged by the Principal Investigator.
You may not qualify if…
- Participation in another investigational drug or device study or treated with an investigational product within 30 days or 5 half-lives, whichever is longer, before investigational product administration in this study.
- History/evidence of clinically relevant pathology related to the cardiovascular system, central nervous system, respiratory tract, gastrointestinal tract, endocrinology, immunology, hematology or any other systemic disorder/major surgeries, that in the opinion of the Principal Investigator would confound the subject's participation and follow-up in the study.
- History of clinically significant food or drug allergy, including known hypersensitivity to cefepime or any other related drugs.
- History of Clostridium difficile induced diarrhea or infection within 1 year before screening.
- Prior exposure to zidebactam.
Where it is running
- Quintiles — Overland Park, Kansas, United States
Full record on ClinicalTrials.gov
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