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

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Avonex

Study type: Interventional

Funder types: Industry

Identifiers

NCT01119677

108HV103

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups

Group 1

Experimental group

Description:

No dose titration

Treatment:

Drug: Avonex

Group 2

Experimental group

Description:

Fast dose titration

Treatment:

Drug: Avonex

Group 3

Experimental group

Description:

Slow dose titration

Treatment:

Drug: Avonex