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

Wockhardt

Status and phase: Completed; Phase 1

Conditions: Serious Gram-negative Infections

Treatments: Drug: Intravenous infusions of WCK 5222; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02707107

W-5222-101

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Have a body mass index of 18 to 30 kg/m2 (both inclusive) calculated as weight (kg)/height(m2).
2. 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.
3. Calculated creatinine clearance ≥80 mL/min (Cockcroft-Gault method).
4. All values of hematology, serum chemistry, coagulation, and urinalysis showing no clinically significant deviations from normal as judged by the Principal Investigator.

Exclusion criteria

1. 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.
2. 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.
3. History of clinically significant food or drug allergy, including known hypersensitivity to cefepime or any other related drugs.
4. History of Clostridium difficile induced diarrhea or infection within 1 year before screening.
5. Prior exposure to zidebactam.

Trial design

20 participants in 2 patient groups, including a placebo group

3 g of zidebactam (1 g q8h) and 6 g of cefepime (2 g q8h) or 6

Active Comparator group

Description:

administered as IV infusions every q8h, over a period of 60 minutes.

Treatment:

Drug: Intravenous infusions of WCK 5222

Placebo

Placebo Comparator group

Description:

administered as IV infusions every q8h, over a period of 60 minutes.

Treatment:

Drug: Placebo