A Study of Avonex® to Determine the Effects of Dose Titration on the Incidence of Flu Like Symptoms in Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01119677
• Date of registration: 06/05/2010
• Primary sponsor: Biogen Idec
• Public title: A Study of Avonex® to Determine the Effects of Dose Titration on the Incidence of Flu Like Symptoms in Healthy Volunteers
• Scientific title: A Randomized, Three-Arm, Dose-Blinded, Parallel-Group Study to Determine the Effect of Avonex® Dose Titration on the Severity and Incidence of Interferon Beta-1a-Related Flu Like Symptoms in Healthy Volunteers
• Date of first enrolment: May 2010
• Target sample size: 120
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01119677
• Study type: Observational
• Study design: Observational Model: Case Control, Time Perspective: Prospective

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Avonex

Primary Outcome(s)

To determine whether titration of Avonex reduces the incidence of flu like symptoms [Time Frame: 8 weeks]

Secondary Outcome(s)

To evaluate the overall safety and tolerability of Avonex IM injections [Time Frame: 8 weeks]

Secondary ID(s)

108HV103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors