DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SINGLE ASCENDING DOSES AND THE EFFECT OF FOOD ON ORAL WCK 4873 IN HEALTHY ADULT VOLUNTEERS
Completed
- Conditions
- 10024970Bacterial PneumoniaRespiratory Tract Infections
- Registration Number
- NL-OMON38693
- Lead Sponsor
- Wockhardt Bio AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 78
Inclusion Criteria
healthy male or female
18 - 65 years inclusive
BMI 18.0 - 30.0 kg/m2 inclusive
non-smoker
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS.
Participation in another drug study within 60 days prior to randomization.
Any donation of blood(products) or significant blood loss within 60 days prior to drug administration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PK<br /><br>Safety<br /><br>Tolerability</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>