MED Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous WCK 5222 (Zidebactam and Cefepime) in Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.