MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous Zidebactam in Healthy Adults

A double-blind, placebo-controlled study where healthy adult subjects will be randomly assigned to receive either of the investigational products (Zidebactam or placebo) in 2 multiple ascending dose (MAD) cohorts.

Primary Objective: to evaluate the safety and tolerability of multiple escalating doses of intravenous (IV) zidebactam in healthy adult human subjects.

Secondary Objective: to evaluate the pharmacokinetics (PK) of multiple escalating doses of IV zidebactam in healthy adult human subjects.

Inclusion criteria

• Have a body mass index of 18 to 30 kg/m2 (both inclusive) calculated as weight (kg)/height (m2).
• Medical history without any major pathology/surgery in the last 6 months prior to screening.
• All values of hematology, serum chemistry, coagulation, and urinalysis showing no clinically significant deviations from normal as judged by the Principal Investigator.
• 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).
• Computerized 12-lead ECG recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the Principal Investigator.

Exclusion criteria

• History of clinically significant food or drug allergy, including known hypersensitivity to β lactam drugs or other related drugs.
• History of Clostridium difficile induced diarrhea or infection within 1 year before screening
• Consumed more than 28 units of alcohol per week at any time in the 6 months before investigational product administration
• 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.