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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2012

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.

Interventions

  • 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
  • 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

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Maximum Serum Concentration (Cmax) of peginterferon beta-1a
    • Time Frame: 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
  • Changes in clinical laboratory assessments
    • Time Frame: Day 1 up to Day 50
  • Vital sign changes
    • Time Frame: Day 1 up to Day 50)
  • Physical exam changes
    • Time Frame: Day 1 up to Day 50
  • Electrocardiogram changes
    • Time Frame: Day 1 up to Day 50
  • Clinician injection site assessment
    • Time Frame: Days 1+2, 22+23

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Biogen
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Biogen

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