To Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ)

A Phase 1, Randomized, Double-Blind Study to Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ) After Intravenous Administrations in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03622008

Enrollment

Registered

2018-08-09

Start date

2018-03-23

Completion date

2018-05-30

Last updated

2018-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotics Causing Adverse Effects in Therapeutic Use

Brief summary

To evaluate the safety, tolerability and pharmacokinetics (PK) of multiple IV doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) administered every 8 hours (q8h) in healthy adult volunteers for 10 days.

Interventions

DRUGFEP-TAZ 4 g

FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV treatments as a q8h infusion (90 min) regimen for 10 days

OTHERPlacebo

Placebo IV

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

double-blind study

Intervention model description

Subjects will receive one of the following IV treatments as a q8h infusion (90 min) regimen for 10 days: * FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) (n=16) * Placebo (n=4)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Have a body Mass Index (BMI) between 18 to 32 kg/m2 (both inclusive). * Medical history without any major pathology. * A sustained supine systolic blood pressure \<150 mm Hg or \>90 mm Hg or a supine diastolic blood pressure \<95 mm Hg or \>50 mm Hg at Screening or Check-in (Day -1). Blood pressure may be retested once in the supine position. * Glomerular filtration rate (GFR) \> 80 mL/min, estimated by the Cockcroft-Gault equation.

Exclusion criteria

* Use of cefepime and/or tazobactam within 60 days prior to study drug administration. * History or evidence of clinically relevant pathology which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.

Design outcomes

Primary

Measure	Time frame
Safety assessed by number of abnormal clinical laboratory test result	every 8 hours
To measure the Maximum Concentration	24 hrs
To measure the Area Under the Curve [AUC]	24 hrs
Safety assessed by number of abnormal physical examinations findings.	every 8 hours
Safety assessed by number of abnormal vital signs findings	every 8 hours
Safety assessed by number of abnormal 12 Lead ECG findings	every 8 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026