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Antibiotic

A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination.

Miami, FL
Phase 1
Recruiting
Research Sponsored by Wockhardt
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, 18 to 45 years of age (inclusive)
Calculated creatinine clearance ≥90 mL/min (Cockcroft-Gault method)
Must not have
History of bleeding disorders
Unable or unwilling to stay in the study center for the required duration as per the protocol or consume the standard meal provided by the study center
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 4, 7
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the safety and how the body processes a combination of ZID-FEP and metronidazole in healthy adults. Participants will receive single doses of ZID-FEP, metron

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Who is the study for?
This trial is for healthy adult men and women who can participate in a study to test the safety of new drug combinations. Participants will receive single doses of Zidebactam-Cefepime (ZID-FEP) and Metronidazole, both alone and together, with breaks in between treatments.Check my eligibility
What is being tested?
The study is testing how safe ZID-FEP combined with Metronidazole is and how these drugs behave in the body when given separately or together. It's a Phase I trial where each participant receives three different treatments across separate periods.See study design
What are the potential side effects?
Possible side effects may include reactions at the injection site, gastrointestinal issues like nausea or diarrhea, headaches, dizziness, or allergic reactions. Since this is a safety study, all potential side effects are closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 45 years old.
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My kidneys are functioning well, with a creatinine clearance rate of 90 mL/min or higher.
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I am not pregnant or breastfeeding, or I cannot become pregnant.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of bleeding disorders.
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I cannot or do not want to stay at the study center as required or eat their meals.
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I am willing and able to follow the study's instructions.
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I have been treated with zidebactam before.
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I have not participated in another drug study or taken any study drugs within the last 30 days or 5 half-lives, whichever is longer.
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I have donated more than 500 mL of blood in the last 2 months.
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I am not an employee, relative of an employee, or directly involved in this study.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 4, 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 4, 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To assess Plasma Pharmacokinetics Parameters
Secondary study objectives
To Assess Plasma Pharmacokinetics Parameters Area Under Concentration
To Assess Plasma Pharmacokinetics Parameters Plasma Clearance
To Assess Plasma Pharmacokinetics Parameters Terminal elimination half-life
+2 more
Other study objectives
Measurement of Plasma PK Parameters
Protein Binding

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Zidebactam CefepimeExperimental Treatment3 Interventions
Zidebactam Cefepime 3gm Vial
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metronidazole
2011
Completed Phase 4
~3810
FEP-ZID
2017
Completed Phase 1
~40

Find a Location

Closest Location:Advanced Pharma CR, LLC· Miami, FL· 995 miles

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

WockhardtLead Sponsor
35 Previous Clinical Trials
3,501 Total Patients Enrolled
Eric Solutions LLCUNKNOWN
1 Previous Clinical Trials
18 Total Patients Enrolled
~20 spots leftby Mar 2026
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