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Pharmacodynamic Biomarkers to Support Biosimilar Development: Interleukin-5 Antagonists

Food and Drug Administration (FDA) · 2020
ClinicalTrials.gov · Datasets · License: Public Domain · 2020
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healthy-subjectspharmacodynamicspharmacokinetics
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.
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