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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Biogen
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Area under the time-concentration curve for serum concentrations of peginterferon beta-1a from time zero to infinity post dose (AUC0-∞)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •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.
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
- Clinician injection site assessment(Days 1+2, 22+23)
- 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)