Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 2: PCSK9 Inhibitors - Alirocumab and Evolocumab
Phase: PHASE1
Conditions: Healthy Subjects, Pharmacokinetics, Pharmacodynamics
Sponsor: Food and Drug Administration (FDA)

Study Title: Pharmacodynamic Biomarkers to Support Biosimilar Development: 
Clinical Study 2 (PCSK9 Inhibitors – Alirocumab and Evolocumab) 
 
Document Title: Clinical Study Protocol – Study No. SCR-007 
 
Document Date: 18 May 2020 
 
NCT Number: NCT04189484 

Digitally signed by David Strauss -S 
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 
cn=David Strauss -S, 0.9.2342.19200300.100.1.1=2000507494 
Date: 2020.06.07 14:58:51 -04'00'