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A Study of Avonex® to Determine the Effects of Dose Titration on the Incidence of Flu Like Symptoms in Healthy Volunteers - NCT01119677-(Clinical Trial 623805)



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City:  St. Paul
State:  
MN
Zip Code:
Conditions: Healthy
Purpose: This is a randomized, 3-arm, dose-blinded, parallel-group study. Subjects will be randomized to one of 3 treatment titration regimes (slow titration over 6 weeks, fast titration over 3 weeks, and no titration).
Study summary:
Criteria: Inclusion Criteria: - Must be healthy males or females aged 18 to 55 years old at the time of informed consent. - Must have a Body Mass Index of 19 to 30 kg/m2, and a minimum body weight of 50.0 kg at Screening. - Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. Exclusion Criteria: - Known history of or positive test result for human immunodeficiency virus (HIV), hepatitis C virus (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for hepatitis B surface antigen [HBsAg] and hepatitis B core antibody [HBcAb]) - Known history of chronic fatigue syndrome or fibromyalgia - Within one month, flu-like illnesses (e.g., gastroenteritis, upper respiratory infection, common cold) - History of severe allergic reactions to any drug or anaphylactic reactions - Known allergy to Avonex or any of its components - Serious infection (e.g., pneumonia, septicemia) within the 3 months prior to Screening or active bacterial or viral infection - History of alcohol or substance abuse (as defined by the Investigator) - Female subjects who are pregnant or currently breastfeeding - Any previous treatment with any interferon product.10. Vaccinations within 2 weeks or 5 half-lives, whichever is longer, prior to Day 1 - Blood donation within 30 days prior to Screening - Use of any tobacco product more than 5 times within 30 days prior to Screening
Study is available at: Research Site
St. Paul, MN
United States

Primary Contact:
Medical Director
Email: neurologyclinicaltrials@biogenidec.com
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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