Plasma and Intrapulmonary Concentrations Study of WCK 5222

A Phase 1, Multiple-Dose, Open-Label Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 5222 (Cefepime and Zidebactam) in Healthy Adult Human Subjects

This is a Phase 1, multiple dose, open-label pharmacokinetic study in healthy adult male and female subjects.

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.