PHA1A
Conditions
Brief summary
This is a Phase 1, multiple dose, open-label pharmacokinetic study in healthy adult male and female subjects.
Interventions
DRUGFEP-ZID
A total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen
Sponsors
Wockhardt
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) greater than or equal to18.5 and less than or equal to 30 (kg per m2) and weight between 55.0 and 100.0 kg (both inclusive). * Medical history without any major pathology as judged by the Investigator. * Forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at screening.
Exclusion criteria
* History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal,endocrine, immunologic, dermatologic, neurological, or psychiatric disease. * Positive alcohol breath test or urine drug screen test at screening or confinement. * Current use or has used tobacco or nicotine containing products 6 month prior to screening. * Positive testing for HIV, Hepatitis B or Hepatitis C. * History or presence of alcohol or drug abuse within the 2 years prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| concentrations of cefepime (FEP) and zidebactam in epithelial lining fluid (ELF) | Day 3 |
| concentrations of cefepime (FEP) and zidebactam in alveolar macrophage (AM) | Day 3 |
Secondary
| Measure | Time frame |
|---|---|
| Number of adverse event reported | Day 3 |
| number variation noted in 12-lead electrocardiogram | Day 3 |
Countries
United States
Outcome results
None listed