NCT02674347

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

January 25, 2016

Last Update Submit

September 24, 2025

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

Cohort 1: 3 g or 6 g of Zidebactam

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

3 g or 6 g ZidebactamDRUG

IV for over a duration of 60 minutes

Also known as: WCK 5107
Cohort 1: 3 g or 6 g of Zidebactam
PlaceboDRUG

IV matching the Investigational drug

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Have a body mass index of 18 to 30 kg/m2 (both inclusive) calculated as weight (kg)/height (m2).
  • Medical history without any major pathology/surgery in the last 6 months prior to screening.
  • All values of hematology, serum chemistry, coagulation, and urinalysis showing no clinically significant deviations from normal as judged by the Principal Investigator.
  • 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).
  • Computerized 12-lead ECG recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the Principal Investigator.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quintiles

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Interventions

zidebactam

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2016

First Posted

February 4, 2016

Study Start

February 1, 2016

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

September 30, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)