Pharmacodynamic Biomarkers to Support Biosimilar Development: Interferon Beta-1A Products

Phase 1 Completed 84 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 interferon beta-1a and peginterferon beta-1a 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 84 healthy subjects assigned to one of three dose groups (low, intermediate, and high) of each drug (interferon beta-1a and peginterferon beta-1a) or placebo.

Timeline

Start: 2020-02-28
Primary completion: 2021-01-26
Completion: 2021-01-26

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Interferon beta-1a	Protein / enzyme biologic	7.5 ug	Intramuscular
Subject	Interferon beta-1a	Protein / enzyme biologic	15 ug	Intramuscular
Subject	Interferon beta-1a	Protein / enzyme biologic	30 ug	Intramuscular
Subject	peginterferon beta-1a	Protein / enzyme biologic	31.25 ug	Subcutaneous
Subject	peginterferon beta-1a	Protein / enzyme biologic	62.5 ug	Subcutaneous
Subject	peginterferon beta-1a	Protein / enzyme biologic	125 ug	Subcutaneous

Indications

No indication recorded.