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

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to determine whether titration of Avonex reduces the severity of flu-like symptoms (FLS). Secondary objectives of this study are to determine whether titration of Avonex reduces the incidence of FLS and to evaluate the overall safety and tolerability of Avonex intramuscular (IM) injections.

Official 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

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Avonex


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Must have a Body Mass Index of 19 to 30 kg/m2, and a minimum body weight of 50.0 kg at Screening. Female participants 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. Key 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 participants 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 NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>No dose titration | Drug: Avonex<br>* Group 1 subjects will receive weekly Avonex 30 mcg (full dose) IM injections from Week 1 to Week 8. Group 2 subjects will titrate in quarter dose increments every week up to a full dose of Avonex over a 3 week period from Week 1 to Week 3 and then continue on full dose from Week 4 to Week 8. Group 3 subjects will titrate in quarter dose increments every 2 weeks up to a full dose of Avonex over a 6 week period from Week 1 to Week 6 and continue on full dose from Week 7 to Week 8<br>|
| Experimental: Group 2<br>Fast dose titration | Drug: Avonex<br>* Group 1 subjects will receive weekly Avonex 30 mcg (full dose) IM injections from Week 1 to Week 8. Group 2 subjects will titrate in quarter dose increments every week up to a full dose of Avonex over a 3 week period from Week 1 to Week 3 and then continue on full dose from Week 4 to Week 8. Group 3 subjects will titrate in quarter dose increments every 2 weeks up to a full dose of Avonex over a 6 week period from Week 1 to Week 6 and continue on full dose from Week 7 to Week 8<br>|
| Experimental: Group 3<br>Slow dose titration | Drug: Avonex<br>* Group 1 subjects will receive weekly Avonex 30 mcg (full dose) IM injections from Week 1 to Week 8. Group 2 subjects will titrate in quarter dose increments every week up to a full dose of Avonex over a 3 week period from Week 1 to Week 3 and then continue on full dose from Week 4 to Week 8. Group 3 subjects will titrate in quarter dose increments every 2 weeks up to a full dose of Avonex over a 6 week period from Week 1 to Week 6 and continue on full dose from Week 7 to Week 8<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether titration of Avonex reduces the incidence of flu like symptoms |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the overall safety and tolerability of Avonex IM injections |  | 8 weeks |