A Phase 1 interventional study of 25G x 1" Needle Autoinjector in Healthy, sponsored by Biogen. Terminated at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-12.
Sponsored by Biogen · Phase 1, Interventional, and Treatment
This is a single-arm, single-center study in healthy volunteers. This study is designed to evaluate the safety of IM injections using single-use autoinjectors with a 25G × 1" needle. The purpose of this study is not to evaluate study treatment; therefore, all injections will be performed with Avonex placebo only; no active IFNβ-1a will be administered.
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.
Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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.
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
This study is terminated, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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