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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119677
• Other study ID #: 108HV103
• Status: Completed
• Phase: Phase 1
• First received: May 6, 2010
• Last updated: November 15, 2017
• Start date: May 5, 2010
• Est. completion date: October 23, 2010

Study information

• Verified date: November 2017
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 23, 2010
• Est. primary completion date: October 23, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Avonex
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

Locations

Country	Name	City	State
United States	Research Site	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether titration of Avonex reduces the incidence of flu like symptoms		8 weeks
Secondary	To evaluate the overall safety and tolerability of Avonex IM injections		8 weeks