A study investigating the biological availability of ALX-0061, a new drug in the treatment of rheumatoid arthritis, after subcutaneous and intravenous administration in healthy volunteers.
Completed
- Conditions
- chronic systemic inflammatory diseaserheumatoid arthritis10003816
- Registration Number
- NL-OMON40925
- Lead Sponsor
- Ablynx NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
Healthy male or female volunteers
Age between 18 and 55 years
BMI between 18.0 - 30.0 kg/m2
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objective:<br /><br><br /><br>To assess the pharmacokinetics of single subcutaneous (s.c.) and intravenous<br /><br>(i.v.) doses of ALX-0061 in healthy volunteers.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objective:<br /><br><br /><br>To assess the pharmacodynamics, safety, tolerability, and immunogenicity of<br /><br>single s.c. and i.v. doses of ALX-0061 in healthy volunteers.</p><br>