A randomized, parallel-group clinical pharmacology study to assess the pharmacokinetics and pharmacodynamics of Tysabri® in healthy volunteers
Completed
- Conditions
- Multiple Sclerosis10029317
- Registration Number
- NL-OMON46349
- Lead Sponsor
- bioeq GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
Healthy males and females.
18-65 years, inclusive, at screening.
BMI: 18.5-32.0 kg/m2.
Weight: 50.0-110.0 kg.
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. Presence of JCV antibodies. In case of participation in another drug study within 90 days before the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetics and pharmacodynamics</p><br>
- Secondary Outcome Measures
Name Time Method <p>N.A</p><br>