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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| peginterferon beta-1a PFS/autoinjector | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Saint Paul | Minnesota | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| BIIB017 (peginterferon beta-1a) Autoinjector | Device | 125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by autoinjector once on either Day 1 or Day 22 |
|
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| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |