Open-label Study Using 50 Mg Liquid Etanercept Subcutaneous Injection in the Thigh to Compare an Auto-injector Device and a Manual Injection in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

August 31, 2004

Primary Completion Date

October 31, 2004

Study Completion Date

October 31, 2004

Conditions
Healthy Men and Women
Interventions
DEVICE

etanercept (ENBREL®) via auto-injector device

single 50 mg subcutaneous dose of liquid etanercept (ENBREL®) in a 1.0 ml pre-filled syringe administered via an auto-injector device manufactured by Scandinavian Health Limited (SHL)

OTHER

Etanercept (ENBREL®) via Manual injection

single 50 mg subcutaneous dose of liquid etanercept (ENBREL®) in a 1.0 ml pre-filled syringe administered via manual injection (reference treatment) to compare to the auto-injection

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY