Plasma and Intrapulmonary Concentrations Study of WCK 5222

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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