Clinical Trial

Test of a New Drug in Healthy Subjects

Study Description

Pharmacodynamic Biomarkers to Support Biosimilar Development: Interleukin-5 Antagonists

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Biological - Mepolizumab

Mepolizumab 3 mg administered SC

Biological - Mepolizumab

Mepolizumab 6 mg administered SC

Biological - Mepolizumab

Mepolizumab 12 mg administered SC

Biological - Mepolizumab

Mepolizumab 24 mg administered SC

Biological - Reslizumab

Reslizumab 0.1 mg/kg administered IV

Biological - Reslizumab

Reslizumab 0.2 mg/kg administered IV

Biological - Reslizumab

Reslizumab 0.4 mg/kg administered IV

Biological - Reslizumab

Reslizumab 0.8 mg/kg administered IV

Biological - Placebo

Placebo (administered either IV or SC)

Additional Information

Official Study Title

Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 1: Interleukin-5 Antagonists - Mepolizumab and Reslizumab

Clinical Trial ID

NCT04183192

ParticipAid ID

eXDNke