At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 3 - Interferon Beta-1A and Peginterferon Beta-1A
In Brief
A Phase 1 clinical trial evaluating Interferon beta-1a, Peginterferon beta-1a, and 1 other intervention for Healthy Subjects and 2 related conditions. Completed, enrolled 84 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Interferon beta-1a 7.5 µg administered IM
Interferon beta-1a 15 µg administered IM
Interferon beta-1a 30 µg administered IM
Peginterferon beta-1a 31.25 µg administered SC
Peginterferon beta-1a 62.5 µg administered SC
Peginterferon beta-1a 125 µg administered SC
Placebo (administered either IM or SC)