A phase 1, single center, randomized, double-blind, placebo-controlled, single (Part 1) and multiple (Part 2) ascending dose study to evaluate the safety,tolerability, pharmacokinetics and pharmacodynamics of M281 administered to healthy volunteers.
Completed
- Conditions
- auto-immuunziekten en ontstekingsziekten.autoimmune diseases and inflammatory diseases
- Registration Number
- NL-OMON43123
- Lead Sponsor
- Momenta Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 74
Inclusion Criteria
healthy male or female subjects
18 - 55 years of age, inclusive
BMI 18 - 30 kilograms/meter2, inclusive
weight 50 -110 kg, inclusive
non smoking
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>To establish the safety and tolerability of ascending single (Part 1) and<br /><br>multiple doses (Part 2) of M281 relative to placebo, administered intravenously<br /><br>(IV) to healthy male and female volunteers at dose intensities that lead to<br /><br>progressively higher levels, and longer periods, of receptor occupancy (RO).</p><br>
- Secondary Outcome Measures
Name Time Method