Clinical Trial

Test of a New Drug in Healthy Subjects

Study Description

Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors

This study is designed to assess pharmacokinetics and pharmacodynamics of evolocumab and alirocumab 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 (evolocumab and alirocumab ) 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 - 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

Additional Information

Official Study Title

Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 2: PCSK9 Inhibitors - Alirocumab and Evolocumab

Clinical Trial ID

NCT04189484

ParticipAid ID

en5v4d