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

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 21, 2025

Primary Completion Date

February 17, 2025

Study Completion Date

February 17, 2025

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.

Trial Locations (1)

33147

Advanced Pharma CR, LLC, Miami

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Eric Solutions LLC

UNKNOWN

lead

Wockhardt

INDUSTRY

NCT06806995 - A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination. | Biotech Hunter | Biotech Hunter