drugset / Trial / NCT01366521
Dose Ranging Pharmacokinetics and Pharmacodynamics Study With Mepolizumab in Asthma Patients With Elevated Eosinophils
RandomizedParallel-groupOpen-labelTreatment
Summary
A multi-center, randomized, open-label, parallel-group, repeat dose study in asthma patients with elevated eosinophils. Eligible subjects will receive 3 doses (28 days apart) of mepolizumab given intravenous (IV) or subcutaneously (SC). Blood samples for safety, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity analysis, as well as safety/tolerability assessments will be collected throughout the study
Timeline
- Start
- 2011-02
- Primary completion
- 2012-03
- Completion
- 2012-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mepolizumab | Monoclonal antibody | 12.5 mg | Intravenous |
| Subject | Mepolizumab | Monoclonal antibody | 75 mg | Intravenous |
| Subject | Mepolizumab | Monoclonal antibody | 125 mg | Intravenous |
| Subject | Mepolizumab | Monoclonal antibody | 250 mg | Intravenous |