At a glance
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Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 1: Interleukin-5 Antagonists - Mepolizumab and Reslizumab
In Brief
A Phase 1 clinical trial evaluating Mepolizumab, Reslizumab, and 1 other intervention for Healthy Subjects and 2 related conditions. Completed, enrolled 72 participants across 1 site.
Detailed Summary
This study is designed to assess pharmacokinetics and pharmacodynamics of mepolizumab and reslizumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 72 healthy subjects assigned to one of four dose groups (low, intermediate low, intermediate high, and high) of each drug (mepolizumab or reslizumab) or placebo.
Study Details
Timeline
Interventions
Mepolizumab 3 mg administered SC
Mepolizumab 6 mg administered SC
Mepolizumab 12 mg administered SC
Mepolizumab 24 mg administered SC
Reslizumab 0.1 mg/kg administered IV
Reslizumab 0.2 mg/kg administered IV
Reslizumab 0.4 mg/kg administered IV
Reslizumab 0.8 mg/kg administered IV
Placebo (administered either IV or SC)