Clinical Trial

Test of a New Drug in Healthy Subjects

Study Description

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

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Biological - Interferon beta-1a

Interferon beta-1a 7.5 µg administered IM

Biological - Interferon beta-1a

Interferon beta-1a 15 µg administered IM

Biological - Interferon beta-1a

Interferon beta-1a 30 µg administered IM

Biological - Peginterferon beta-1a

Peginterferon beta-1a 31.25 µg administered SC

Biological - Peginterferon beta-1a

Peginterferon beta-1a 62.5 µg administered SC

Biological - Peginterferon beta-1a

Peginterferon beta-1a 125 µg administered SC

Biological - Placebo

Placebo (administered either IM or SC)

Additional Information

Official Study Title

Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 3 - Interferon Beta-1A and Peginterferon Beta-1A

Clinical Trial ID

NCT04183491

ParticipAid ID

eZ6Pve