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

Study Overview
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Brief Summary
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Study to evaluate the safety, tolerability and pharmacokinetics of multiple escalating doses of intravenous WCK 5222 (Zidebactam and Cefepime) in healthy adult human subjects.

Official Title
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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

Conditions
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Serious Gram-negative Infections

Intervention / Treatment
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* Drug: Intravenous infusions of WCK 5222
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3 g of zidebactam (1 g q8h) and 6 g of cefepime (2 g q8h) or 6<br>administered as IV infusions every q8h, over a period of 60 minutes. | Drug: Intravenous infusions of WCK 5222<br> <br> |
| Placebo Comparator: Placebo<br>administered as IV infusions every q8h, over a period of 60 minutes. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration |  | 7 days | 
| Time to Cmax |  | 7 days |