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The objective of the study has been achieved with fewer subjects than planned.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects to self-administer 4 IM injections | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25G x 1" Needle Autoinjector | Device | All subjects will self-administer 4 IM injections using single-use autoinjectors. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent AEs reported when using the single-use autoinjector with a 25G x 1" needle | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence (post-injection) of clinician-assessed injection site erythema, induration, tenderness, or warmth | 24 hours | |
| Incidence of abnormal post-injection needle observations | 24 hours | |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Toronto | Ontario | Canada |
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| Incidence of AEs associated with abnormal post-injection needle observations |
| 24 hours |