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

Wockhardt1 site in 1 country20 target enrollmentMarch 2016

ConditionsSerious Gram-negative Infections

InterventionsIntravenous infusions of WCK 5222 Placebo

DrugsIntravenous infusions of WCK 5222 Placebo

Overview

Phase: Phase 1
Intervention: Intravenous infusions of WCK 5222
Conditions: Serious Gram-negative Infections
Sponsor: Wockhardt
Enrollment: 20
Locations: 1
Primary Endpoint: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

April 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wockhardt

Responsible Party

Sponsor

Eligibility Criteria

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.