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

PHASE1CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

February 28, 2020

Primary Completion Date

January 26, 2021

Study Completion Date

January 26, 2021

Conditions
Healthy SubjectsPharmacokineticsPharmacodynamics
Interventions
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)

Trial Locations (1)

53095

Spaulding Clinical Research, West Bend

All Listed Sponsors
collaborator

Spaulding Clinical Research LLC

OTHER

lead

Food and Drug Administration (FDA)

FED

NCT04183491 - Pharmacodynamic Biomarkers to Support Biosimilar Development: Interferon Beta-1A Products | Biotech Hunter | Biotech Hunter