A Multiple-Dose, Open-Label, Phase 1, Pharmacokinetic, Pharmacodynamic, and Safety Study of Avonex® in Chinese Healthy Volunteer Subjects

Biogen1 site in 1 country24 target enrollmentStarted: August 2011Last updated: November 4, 2011

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: Biogen
Enrollment: 24
Locations: 1
Primary Endpoint: Tlag

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

Rationale for the Study:

The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Avonex in Chinese healthy volunteer subjects. Data from this study will be used to support registration of Avonex in China.

Study Design:

This is a multiple-dose, single-arm, open-label, PK/PD and safety study. Four weekly injections of Avonex will be administered intramuscularly (IM). Frequent (intensive) blood samples will be collected with the first and fourth injections of Avonex, and a sparse blood sample will be collected with the second and third injections of Avonex.

Detailed Description

Rationale for the Study:

Study Design:

Four Avonex IM injections will be administered in this study. Due to the long-term use of Avonex by MS patients, a multiple-dose PK/PD study is necessary in order to provide adequate information to evaluate changes in drug concentrations over time in Chinese healthy subjects. Serum levels of interferon beta in Caucasian healthy volunteers have been shown to peak between 3 and 15 hours after administration of Avonex IM at the dose being used in this study and have been shown to decline at a rate consistent with a 10-hour elimination half-life; therefore, accumulation of interferon beta following multiple weekly Avonex IM injections is not anticipated.

Study Design

Study Type: Interventional
Allocation: Na
Intervention Model: Single Group
Primary Purpose: Basic Science
Masking: None

Eligibility Criteria

Ages: 18 Years to 50 Years (Adult)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
•Subjects of Chinese origin (at least both maternal and paternal grandparents of Chinese origin).
•Body mass index (BMI) within the range of 18.5 to 30 kg/m2 (inclusive).
•All male subjects and 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

•History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Day
•History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 6 months prior to Day
•Any clinically significant presence (as determined by the Investigator) of cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease.
•Positive test result for hepatitis C antibody (HCV Ab), or current hepatitis B infection at Screening.
•Known history of human immunodeficiency virus (HIV).
•Clinically significant abnormal laboratory values.
•History of alcohol abuse (as defined by the Investigator), or a positive blood screen test for presence for alcohol at Screening.
•History of drug abuse (as defined by the Investigator), or a positive urinary screen test for presence of cocaine and morphine.
•Premalignant and malignant disease.
•History of clinically significant severe allergic or anaphylactic reactions.
•Known allergy to any component of the Avonex formulation.
•History of hypersensitivity or intolerance to prophylactic analgesic medication that would preclude use during the study.
•Clinically significant abnormal electrocardiogram (ECG) values as determined by the Investigator.
•Known allergy to interferon beta-1a.
•Active bacterial or viral infection.
•Female subjects who are pregnant or currently breastfeeding.
•Previous participation in another investigational drug study within the last 1 month or 7 half-lives, whichever is longer, or previous participation in this study.
•Treatment with any prescription medication within 14 days of Day
•Treatment with any over-the-counter products within the 14 days prior to Day
•Donation of blood (500 mL or greater) within 56 days prior to Day
•Inability to comply with study requirements

Arms & Interventions

Avonex

Experimental

4 weekly injections of Avonex (IM)

Intervention: Avonex (Drug)