Healthy, Multiple Sclerosis
Conditions
Keywords
SC, PEG, Inteferon, PK, Subcutaneous, PEGylated, Autoinjector, Injectable, MS
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.
Interventions
DEVICEBIIB017 (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
DEVICEBIIB017 (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
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the time-concentration curve for serum concentrations of peginterferon beta-1a from time zero to infinity post dose (AUC0-∞) | For 11 days (multiple timepoints) after each dose on Day 1 and 22 |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| Maximum Serum Concentration (Cmax) of peginterferon beta-1a | For 11 days (multiple timepoints) after each dose on Day 1 and 22 |
| Electrocardiogram changes | Day 1 up to Day 50 |
| Clinician injection site assessment | Days 1+2, 22+23 |
| Physical exam changes | Day 1 up to Day 50 |
Countries
United States
Outcome results
None listed