drugset / Trial / NCT01366521

Dose Ranging Pharmacokinetics and Pharmacodynamics Study With Mepolizumab in Asthma Patients With Elevated Eosinophils

NCT01366521

Phase 2 Completed 70 enrolled GlaxoSmithKline
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

EvaluationDrugModalityDoseRoute
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

Indications