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

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of Intravenous Zidebactam in Healthy Adult Human Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: 3 g or 6 g Zidebactam; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Quintiles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 3 g or 6 g Zidebactam; IV for over a duration of 60 minutes; Other Names: WCK 5107
Placebo Comparator: 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.	Drug: Placebo; IV matching the Investigational drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability will be evaluated by reported AEs, clinical observations, vital signs measurements, and physical examination findings.	14 days
Safety and tolerability will be evaluated by 12-lead safety ECG results and clinical laboratory test results	14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic parameters -maximum plasma concentration will be evaluated.	7 days
Pharmacokinetic parameters- area under the plasma concentration-time curve from zero (pre-dose) to 8 hours will be evaluated.	7 days
Pharmacokinetic parameters- terminal half life etc will be evaluated	7 days

Collaborators and Investigators

• Sponsor: Wockhardt
• Collaborators: Quintiles, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: January 25, 2016
• First Submitted That Met QC Criteria: February 1, 2016
• First Posted (Estimated): February 4, 2016

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: zidebactam
• Other Study ID Numbers: W-5107-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO