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

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to compare Pharmacokinetics of liquid etanercept that is administered to healthy subjects aged 18-55 by an auto-injector device and manual injection (each subject received both injections).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Amgen
• Treatments: Etanercept

Criteria

Inclusion Criteria:

• Healty men and women

• Aged 18-55 years at time of screening

• BMI 18-31 kg/m2 inclusive

• Free of any clinically significant disease

• Willing to reside in research facility 4 consecutive nights 2 times and to attend follow up visits

• Willing to sign consent

• Negative HIV, hepatitis B and C, and urine pregnancy tests

Exclusion Criteria:

• Unstable medical condition (hospitalized within 30 days, myocardial infarction or major surgery within 6 months, or seizure within 12 months of study day 1)

• Current active infecton, history of infections, or condition which may predispose infection (such as diabetes)

• Clinically significant abnormality in laboratory samples done while screening

• history of tuberculosis

• donated blood within 30 days of screening

• Use of prescription or over-the-counter medication during the study/

• History of smoking or use of tobacco within 30 days of screening

• Positive urine scree for alcohol or drugs of abuse at screening or the day prior to dosing

• Unwilling to pracitce contraception for the duration ot the study

• Any other condition which could interfere with obtaining data required by the protocol