NCT04189484 - Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 7, 2020

Primary Completion Date

April 7, 2021

Study Completion Date

April 7, 2021

Conditions

Healthy SubjectsPharmacokineticsPharmacodynamics

Interventions

BIOLOGICAL

Evolocumab

Evolocumab 21 mg administered SC

BIOLOGICAL

Evolocumab

Evolocumab 35 mg administered SC

BIOLOGICAL

Evolocumab

Evolocumab 70 mg administered SC

BIOLOGICAL

Evolocumab

Evolocumab 140 mg administered SC

BIOLOGICAL

Alirocumab

Alirocumab 15 mg administered SC

BIOLOGICAL

Alirocumab

Alirocumab 25 mg administered SC

BIOLOGICAL

Alirocumab

Alirocumab 50 mg administered SC

BIOLOGICAL

Alirocumab

Alirocumab 100 mg administered SC

BIOLOGICAL

Placebo

Placebo administered 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