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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)

Intervention Type DEVICE

125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by PFS once on either Day 1 or Day 22

BIIB017 (peginterferon beta-1a) Autoinjector

Intervention Type DEVICE

125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by autoinjector once on either Day 1 or Day 22

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.

Group Type EXPERIMENTAL

BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)

Intervention Type DEVICE

125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by PFS once on either Day 1 or Day 22

BIIB017 (peginterferon beta-1a) Autoinjector

Intervention Type DEVICE

125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by autoinjector once on either Day 1 or Day 22

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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BIIB017 BIIB017

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes