Peginterferon Beta-1a (BIIB017) Autoinjector Pharmacokinetic Study in Healthy Volunteers

June 12, 2014 updated by: Biogen

A Randomized, Open-Label, Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profile, Safety, and Tolerability of Peginterferon Beta-1a (BIIB017) Delivered by Pre-filled Syringe (PFS) or Autoinjector in Healthy Volunteers

The purpose of this study is to characterize the pharmacokinetic (PK) profile, safety, and tolerability of peginterferon beta-1a (BIIB017) delivered by the single-use autoinjector or prefilled syringe (PFS) in healthy volunteers to support the development of the autoinjector.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, open-label, 2-sequence, 2-period crossover study that will be conducted at a single site in the United States to characterize the PK profile, safety and tolerability of peginterferon beta-1a delivered by autoinjector or PFS. Participants will be randomized in a 1:1 ratio to receive a single dose of peginterferon beta-1a at Day 1 delivered by either autoinjector or PFS, followed by a single dose of peginterferon beta 1a delivered by the other device at Day 22. The total duration of study participation is up to 3 months for each participant. Participants will complete a follow-up visit at Day 50 after the end of treatment period.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • St. Paul, Minnesota, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

1. Must have a body mass index (BMI) of 19 to 29 kg/m^2, inclusive, and a minimum body weight of 50.0 kg

Key Exclusion Criteria:

  1. History of any clinically significant laboratory abnormalities, malignancies, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases
  2. Female subjects who are pregnant or breastfeeding
  3. Any previous treatment with prescription or investigational pegylated drugs.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: peginterferon beta-1a PFS/autoinjector
A single dose of peginterferon beta-1a 125 mcg administered by prefilled syringe (PFS) on Day 1, then by a single dose of peginterferon beta-1a 125 mcg by autoinjector on Day 22.
Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)
125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by PFS once on either Day 1 or Day 22
Other Names:
  • BIIB017
Device: BIIB017 (peginterferon beta-1a) Autoinjector
125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by autoinjector once on either Day 1 or Day 22
Other Names:
  • BIIB017
Experimental: peginterferon beta-1a autoinjector / PFS
A single dose of peginterferon beta-1a 125 mcg administered by autoinjector on Day 1, then by a single dose of peginterferon beta-1a 125 mcg by prefilled syringe (PFS) on Day 22.
Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)
125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by PFS once on either Day 1 or Day 22
Other Names:
  • BIIB017
Device: BIIB017 (peginterferon beta-1a) Autoinjector
125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by autoinjector once on either Day 1 or Day 22
Other Names:
  • BIIB017

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the time-concentration curve for serum concentrations of peginterferon beta-1a from time zero to infinity post dose (AUC0-∞)
Time Frame: For 11 days (multiple timepoints) after each dose on Day 1 and 22
For 11 days (multiple timepoints) after each dose on Day 1 and 22

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum Serum Concentration (Cmax) of peginterferon beta-1a
Time Frame: For 11 days (multiple timepoints) after each dose on Day 1 and 22
For 11 days (multiple timepoints) after each dose on Day 1 and 22
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Day 1 up to Day 50
Day 1 up to Day 50
Changes in clinical laboratory assessments
Time Frame: Day 1 up to Day 50
Day 1 up to Day 50
Vital sign changes
Time Frame: Day 1 up to Day 50)
Day 1 up to Day 50)
Physical exam changes
Time Frame: Day 1 up to Day 50
Day 1 up to Day 50
Electrocardiogram changes
Time Frame: Day 1 up to Day 50
Day 1 up to Day 50
Clinician injection site assessment
Time Frame: Days 1+2, 22+23
Days 1+2, 22+23

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

May 31, 2012

First Submitted That Met QC Criteria

May 31, 2012

First Posted (Estimate)

June 4, 2012

Study Record Updates

Last Update Posted (Estimate)

June 13, 2014

Last Update Submitted That Met QC Criteria

June 12, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105HV103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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