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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-04-30

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.

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Detailed Description

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Conditions

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Serious Gram-negative Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

Intravenous infusions of WCK 5222

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Intravenous infusions of WCK 5222

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes