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

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy; Multiple Sclerosis

Treatments: Device: BIIB017 (peginterferon beta-1a) Autoinjector; Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01610310

105HV103

Details and patient eligibility

About

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 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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

peginterferon beta-1a PFS/autoinjector

Experimental group

Description:

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.

Treatment:

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

Device: BIIB017 (peginterferon beta-1a) Autoinjector

peginterferon beta-1a autoinjector / PFS

Experimental group

Description:

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.

Treatment:

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

Device: BIIB017 (peginterferon beta-1a) Autoinjector