NCT04183192View on ClinicalTrials.gov

Pharmacodynamic Biomarkers to Support Biosimilar Development: Interleukin-5 Antagonists

PHASE1CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

February 17, 2020

Primary Completion Date

April 4, 2021

Study Completion Date

April 4, 2021

Conditions
Healthy SubjectsPharmacokineticsPharmacodynamics
Interventions
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)

Trial Locations (1)

53095

Spaulding Clinical Research, West Bend

All Listed Sponsors
collaborator

Spaulding Clinical Research LLC

OTHER

lead

Food and Drug Administration (FDA)

FED

NCT04183192 - Pharmacodynamic Biomarkers to Support Biosimilar Development: Interleukin-5 Antagonists | Biotech Hunter | Biotech Hunter