Plasma and Intrapulmonary Concentrations Study of WCK 5222

Wockhardt

Status and phase: Completed; Phase 1

Conditions: PHA1A

Treatments: Drug: FEP-ZID

Study type: Interventional

Funder types: Industry

Identifiers

NCT03630094

W-5222-104

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

FEP-ZID via intravenous

Experimental group

Description:

total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen

Treatment:

Drug: FEP-ZID