Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Escalating Doses of Intravenous WCK 4282 in Healthy Adult Human Subjects

Completed

• Conditions: Infectious diseases; 10004018

• Registration Number: NL-OMON38943
• Lead Sponsor: Wockhardt Bio AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

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>n/a</p><br>