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

NCT06806995 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-16

No results posted yet for this study

Summary

This is a Phase I, Single-Center, Open-Label study evaluating the safety and pharmacokinetics of single doses of ZID-FEP and metronidazole alone or in combination utilizing a 3-period, crossover study design. Thirty eligible male and female healthy adult subjects will participate in the study and receive single doses of (1) ZID-FEP 3g IV (ZID 1 g plus FEP 2 g) administered over 1 hour (h); (2) metronidazole 0.5 g IV alone administered over 1 h; and (3) metronidazole 0.5 g IV over 1 h, followed by ZID-FEP 3g IV over 1 h over 3 treatment periods separated by a 48 h washout period.

Conditions

  • PHA1A

Interventions

DRUG

Zidebactam-Cefepime

(1) ZID-FEP 3g IV (ZID 1 g plus FEP 2 g) administered over 1 hour (h)

DRUG

Metronidazole

(2) metronidazole 0.5 g IV alone administered over 1 h

DRUG

FEP-ZID

(3) metronidazole 0.5 g IV over 1 h, followed by ZID-FEP 3g IV over 1 h over 3 treatment periods separated by a 48 h washout period.

Sponsors & Collaborators

  • Eric Solutions LLC

    collaborator UNKNOWN

  • Wockhardt

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-21
Primary Completion
2025-02-17
Completion
2025-02-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06806995 on ClinicalTrials.gov