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
NCT01313364 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2011-08-12
Summary
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.
Conditions
- Healthy
Interventions
- DEVICE
-
25G x 1" Needle Autoinjector
All subjects will self-administer 4 IM injections using single-use autoinjectors.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-03-31
- Primary Completion
- 2011-04-30
- Completion
- 2011-04-30
Countries
- Canada
Study Locations
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