Compare Actions in Healthy Volunteer of 50 mg Etanercept Injection Using an Auto-injector Device and Manual Injection

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

October 31, 2003

Primary Completion Date

January 31, 2004

Study Completion Date

January 31, 2004

Conditions
Healthy Men and Women
Interventions
DEVICE

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

DRUG

Etanercept (ENBREL®)

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)

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY