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

Biogen55 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Multiple Sclerosis

Interventions

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

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Research Site

Saint Paul, Minnesota, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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