NCT01416207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 12, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 4, 2011

Status Verified

November 1, 2011

Enrollment Period

2 months

First QC Date

June 30, 2011

Last Update Submit

November 3, 2011

Conditions

Healthy

Outcome Measures

Primary Outcomes (15)

  • Cmax

    Participants will be followed for the duration of the study; and expected 2 months

  • Tmax

    Participants will be followed for the duration of the study; and expected 2 months

  • AUC 0-t

    Participants will be followed for the duration of the study; and expected 2 months

  • AUC 0-infinity

    Participants will be followed for the duration of the study; and expected 2 months

  • T 1/2

    Participants will be followed for the duration of the study; and expected 2 months

  • Tlag

    Participants will be followed for the duration of the study; and expected 2 months

  • Ka

    Participants will be followed for the duration of the study; and expected 2 months

  • T 1/2ab

    Participants will be followed for the duration of the study; and expected 2 months

  • Kcl

    Participants will be followed for the duration of the study; and expected 2 months

  • Kir

    Participants will be followed for the duration of the study; and expected 2 months

  • Emax

    Participants will be followed for the duration of the study; and expected 2 months

  • Tmax(E)

    Participants will be followed for the duration of the study; and expected 2 months

  • Eauc

    Participants will be followed for the duration of the study; and expected 2 months

  • Induction ratio

    Participants will be followed for the duration of the study; and expected 2 months

  • T1/2 return to baseline

    Participants will be followed for the duration of the study; and expected 2 months

Secondary Outcomes (6)

  • Number of Adverse Events as a measure of safety and tolerability

    Participants will be followed for the duration of the study; and expected 2 months

  • Number of Serious Adverse Events as a measure of safety and tolerability

    Participants will be followed for the duration of the study; and expected 2 months

  • Changes in lab assessments

    Participants will be followed for the duration of the study; and expected 2 months

  • Changes in vital signs

    Participants will be followed for the duration of the study; and expected 2 months

  • Changes in physical examinations

    Participants will be followed for the duration of the study; and expected 2 months

  • +1 more secondary outcomes

Study Arms (1)

Avonex

EXPERIMENTAL

4 weekly injections of Avonex (IM)

Drug: Avonex

Interventions

AvonexDRUG

4 weekly injections of Avonex (IM)

Also known as: Interferon-β1a
Avonex

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Day 1.
  • History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 6 months prior to Day 1.
  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Shanghai, China

Location

MeSH Terms

Interventions

Interferon beta-1a

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2011

First Posted

August 12, 2011

Study Start

August 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

November 4, 2011

Record last verified: 2011-11

Locations

CN(1)