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

An Open-label, Randomized, 2-period Crossover Study to Compare the Pharmacokinetics of a 50-mg Dose of Liquid Etanercept Administered to Healthy Subjects by Subcutaneous Injection Using an Auto-Injector Device and Manual Injection

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).

This single-center, randomized, open-label, 2-period, 2-sequence, 2-treatment, crossover study in healthy men and women compared the pharmacokinetics (PK) and safety profiles of two 50-mg subcutaneous (SC) injections of etanercept liquid (in a 1.0-mL prefilled syringe): (1) using a disposable auto-injector device, and (2) using a standard manual injection. Each subject received both injections in the abdomen, separated by a washout period of 28 days.

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