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 | Terminated Phase 1

• 1 other identifier: 108HV104
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent AEs reported when using the single-use autoinjector with a 25G x 1" needle

  24 hours

Secondary Outcomes (3)

• Incidence (post-injection) of clinician-assessed injection site erythema, induration, tenderness, or warmth

  24 hours

• Incidence of abnormal post-injection needle observations

  24 hours

• Incidence of AEs associated with abnormal post-injection needle observations

  24 hours

Study Arms (1)

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.

Device: 25G x 1" Needle Autoinjector

Interventions

25G x 1" Needle Autoinjector DEVICE

All subjects will self-administer 4 IM injections using single-use autoinjectors.

All subjects to self-administer 4 IM injections

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males or females, aged 18 to 65 years, inclusive, at time of informed consent
• Able to understand and comply with the protocol
• Must be English or French speaking
• At the investigator's opinion, must be willing and able to perform self-injections into the right and left thighs with the single-use autoinjector

You may not qualify if:

• Abnormal screening blood tests determined to be clinically significant by the Investigator
• Treatment with any systemic anticoagulant within the previous 30 days
• Treatment with aspirin within the previous 7 days or nonsteroidal anti-inflammatory drugs (NSAIDs) within the previous 3 days
• History of severe allergic or anaphylactic reactions
• History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, pyschiatric, renal, and/or other major disease including bleeding disorders
• Current enrollment in any other investigational study
• Female subjects who are currently pregnant
• History of alcohol or substance abuse or a positive drug screening test on day 1

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Toronto, Ontario, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 11, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 12, 2011

Record last verified: 2011-08

Locations

CA (1)