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

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

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-04-30

Brief Summary

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Study to evaluate the safety and tolerability of multiple escalating doses of intravenous (IV) Zidebactam in healthy adult human subjects.

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Detailed Description

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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.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1: 3 g or 6 g of Zidebactam

Cohort 1 (Zidebactam): 3 g of Zidebactam (1 g every 8 hours \[q8h\]) (n=8) IV infusions administered over 60 minutes.

Cohort 2 (Zidebactam or placebo): 6 g of Zidebactam (2 g q8h) (n=8) IV infusions administered over 60 minutes.

Group Type EXPERIMENTAL

3 g or 6 g Zidebactam

Intervention Type DRUG

IV for over a duration of 60 minutes

Placebo

Cohort 1: Placebo every 8 hours \[q8h\] (n=2) IV infusions administered over 60 minutes.

Cohort 2: Placebo every q8h (n=2) IV infusions administered over 60 minutes.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV matching the Investigational drug

Interventions

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3 g or 6 g Zidebactam

IV for over a duration of 60 minutes

Intervention Type DRUG

Placebo

IV matching the Investigational drug

Intervention Type DRUG

Other Intervention Names

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WCK 5107

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. Medical history without any major pathology/surgery in the last 6 months prior to screening.
3. All values of hematology, serum chemistry, coagulation, and urinalysis showing no clinically significant deviations from normal as judged by the Principal Investigator.
4. 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.
5. Calculated creatinine clearance ≥80 mL/min (Cockcroft-Gault method).
6. 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

1. History of clinically significant food or drug allergy, including known hypersensitivity to β lactam drugs or other related drugs.
2. History of Clostridium difficile induced diarrhea or infection within 1 year before screening
3. Consumed more than 28 units of alcohol per week at any time in the 6 months before investigational product administration
4. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes