A Safety Study in Healthy Volunteers of the Single-Use Autoinjector Containing Placebo of BG9418 Interferon Beta-1a With a 25-Gauge × 1-Inch Needle
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Safety Study in Healthy Volunteers of the Single-Use Autoinjector Containing Placebo of BG9418 Interferon Beta-1a With a 25-Gauge × 1-Inch Needle|
- Incidence of treatment-emergent AEs reported when using the single-use autoinjector with a 25G x 1" needle [ Time Frame: 24 hours ]
- Incidence (post-injection) of clinician-assessed injection site erythema, induration, tenderness, or warmth [ Time Frame: 24 hours ]
- Incidence of abnormal post-injection needle observations [ Time Frame: 24 hours ]
- Incidence of AEs associated with abnormal post-injection needle observations [ Time Frame: 24 hours ]
|Study Start Date:||March 2011|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: All subjects to self-administer 4 IM injections
Subjects will be recruited and stratified into BMI groups: <18.5 kg/m2, 18.5 to 24.9 kg/m2, 25 to 29.99 kg/m2, and >30 kg/m2 all with 20 subjects. To maintain a balance between sexes that is representative of the MS population, approximately 50 to 70% of subjects within each BMI group should be female.
Device: 25G x 1" Needle Autoinjector
All subjects will self-administer 4 IM injections using single-use autoinjectors.
This is a single-arm, single-center study in healthy volunteers. The study is designed to evaluate the safe use of the single-use autoinjector with a 25G × 1" needle in subjects of varying body mass indices (BMIs). Because this is a safety study of the injector, the injections contain Avonex excipients only; no active IFNβ-1a will be administered.
During the study, each subject will self-administer 4 IM injections using single-use autoinjectors.
Subjects will self-administer the first 2 injections (1 in each thigh) and then repeat the process approximately 60 to 90 minutes later. A Trainer/Observer will prepare the autoinjector for each injection, monitor each injection, and assess the subject for AEs during the injection process and up to the time of discharge from the unit. The Trainer/Observer will also visually inspect the needle pre- and post-injection and record their findings. The Investigator or designee (physician or nurse) will assess injection sites for erythema, induration, tenderness, or warmth.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313364
|Toronto, Ontario, Canada|