Pharmacodynamic Biomarkers to Support Biosimilar Development: Interleukin-5 Antagonists

Phase 1 Completed 72 enrolled Food and Drug Administration (FDA) Spaulding Clinical Research LLC · collab

RandomizedParallel-groupDouble-blindOther

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.

Timeline

Start: 2020-02-17
Primary completion: 2021-04-04
Completion: 2021-04-04

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mepolizumab	Monoclonal antibody	3 mg	Subcutaneous
Subject	Mepolizumab	Monoclonal antibody	6 mg	Subcutaneous
Subject	Mepolizumab	Monoclonal antibody	12 mg	Subcutaneous
Subject	Mepolizumab	Monoclonal antibody	24 mg	Subcutaneous
Subject	Reslizumab	Monoclonal antibody	0.1 mg/kg	Intravenous
Subject	Reslizumab	Monoclonal antibody	0.2 mg/kg	Intravenous
Subject	Reslizumab	Monoclonal antibody	0.4 mg/kg	Intravenous
Subject	Reslizumab	Monoclonal antibody	0.8 mg/kg	Intravenous

Indications

No indication recorded.