Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors

Phase 1 Completed 72 enrolled Food and Drug Administration (FDA) Spaulding Clinical Research LLC · collab

RandomizedParallel-groupDouble-blindOther

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.

Timeline

Start: 2020-01-07
Primary completion: 2021-04-07
Completion: 2021-04-07

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alirocumab	Monoclonal antibody	15 mg	Subcutaneous
Subject	Alirocumab	Monoclonal antibody	25 mg	Subcutaneous
Subject	Alirocumab	Monoclonal antibody	50 mg	Subcutaneous
Subject	Alirocumab	Monoclonal antibody	100 mg	Subcutaneous
Subject	Evolocumab	Monoclonal antibody	21 mg	Subcutaneous
Subject	Evolocumab	Monoclonal antibody	35 mg	Subcutaneous
Subject	Evolocumab	Monoclonal antibody	70 mg	Subcutaneous
Subject	Evolocumab	Monoclonal antibody	140 mg	Subcutaneous

Indications

No indication recorded.