Peginterferon Beta-1a (BIIB017) Autoinjector Pharmacokinetic Study in Healthy Volunteers
- Conditions
- HealthyMultiple Sclerosis
- Interventions
- Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)Device: BIIB017 (peginterferon beta-1a) Autoinjector
- Registration Number
- NCT01610310
- Lead Sponsor
- Biogen
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
- 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
- History of any clinically significant laboratory abnormalities, malignancies, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases
- Female subjects who are pregnant or breastfeeding
- Any previous treatment with prescription or investigational pegylated drugs.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description peginterferon beta-1a PFS/autoinjector BIIB017 (peginterferon beta-1a) 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. peginterferon beta-1a PFS/autoinjector BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS) 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. peginterferon beta-1a autoinjector / PFS BIIB017 (peginterferon beta-1a) Pre-filled syringe (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. peginterferon beta-1a autoinjector / PFS BIIB017 (peginterferon beta-1a) Autoinjector 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.
- Primary Outcome Measures
Name Time Method Area under the time-concentration curve for serum concentrations of peginterferon beta-1a from time zero to infinity post dose (AUC0-β) For 11 days (multiple timepoints) after each dose on Day 1 and 22
- Secondary Outcome Measures
Name Time Method Maximum Serum Concentration (Cmax) of peginterferon beta-1a 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) Day 1 up to Day 50 Changes in clinical laboratory assessments Day 1 up to Day 50 Vital sign changes Day 1 up to Day 50) Physical exam changes Day 1 up to Day 50 Electrocardiogram changes Day 1 up to Day 50 Clinician injection site assessment Days 1+2, 22+23
Trial Locations
- Locations (1)
Research Site
πΊπΈSt. Paul, Minnesota, United States