At a glance
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Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 2: PCSK9 Inhibitors - Alirocumab and Evolocumab
In Brief
A Phase 1 clinical trial evaluating Evolocumab, Alirocumab, and 1 other intervention for Healthy Subjects and 2 related conditions. Completed, enrolled 72 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Evolocumab 21 mg administered SC
Evolocumab 35 mg administered SC
Evolocumab 70 mg administered SC
Evolocumab 140 mg administered SC
Alirocumab 15 mg administered SC
Alirocumab 25 mg administered SC
Alirocumab 50 mg administered SC
Alirocumab 100 mg administered SC
Placebo administered SC