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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

This study has been terminated.
(The objective of the study has been achieved with fewer subjects than planned.)
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01313364
First received: March 10, 2011
Last updated: August 11, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Device: 25G x 1" Needle Autoinjector
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Incidence of treatment-emergent AEs reported when using the single-use autoinjector with a 25G x 1" needle [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence (post-injection) of clinician-assessed injection site erythema, induration, tenderness, or warmth [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Incidence of abnormal post-injection needle observations [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Incidence of AEs associated with abnormal post-injection needle observations [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: March 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313364

Locations
Canada, Ontario
Research Site
Toronto, Ontario, Canada
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Medical Director, Biogen Idec
ClinicalTrials.gov Identifier: NCT01313364     History of Changes
Other Study ID Numbers: 108HV104
Study First Received: March 10, 2011
Last Updated: August 11, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Interferon-beta
Interferons
Interferon beta 1a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 16, 2013