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
Study Details
A single-center, open-label, randomized study with a screening period of up to 21 days. Following that, eligible men and women will receive 50 mg of etanercept subcutaneously in the thigh to compare injection by auto-injection device to manual injection (each injection separated by 28 days)
Protocol Summary
Ratio of the geometric mean of etanercept (ENBREL®) administered by auto-injector Scandinavian Health Limited-SHL) to etanercept administered by manual injection for the pharmacokinetic (PK) parameter of AUC(0-t)
Timeframe: 28 days following each treatment arm
Secondary includes the pharmokinetic parameter to measure the etanercept (ENBREL®) AUC (0-x), area under the curve
Timeframe: 28 days: timepoint at which outcome measure is assessed following each treatment arm
Safety Events measured by number of adverse events and retationship to treatment
Timeframe: 28 days following each treatment arm (total of 77 days including screening)
Any significant changes from baseline in Vital Signs and physical examinations
Timeframe: Baseline and 28 days following each treatment arm (total of 77 days including screening)
Any Clinically Significant changes in clinical laboratory tests will be noted.
Timeframe: Collected screening, Day -1 in both treatment periods, and day 15 in treatment period 2
12-lead Electrocardiograms will be performed and saved with subject source records
Timeframe: Performed at screening and day 15 in Treatment B
Blood samples obtained to measure seroreactivitiy to etanercept at baseline and following treatment
Timeframe: Predose in each treatment period and 28 days following dosing in treatment period B
Secondary includes measure of pharmacokinetic parameter of Tmax, the time to reach maximum concentration
Timeframe: 28 days following each treatment period the outcome will be measured
Secondary outcome to measure t 1/2: elimination half-life for etanercept
Timeframe: Outcome to be measured 28 days following each treatment
Secondary to include etanercept pharmacokinetic parameter of CL/F: apparent clearance
Timeframe: Measurement assessed at 29 day timepoint following each treatment arm