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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002912-28 |
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The primary objective of this study is to characterise the pharmacokinetics (PK) of BIIB017 (Peginterferon Beta-1a) administered as a single 125 μg subcutaneous (SC) dose in Japanese and Caucasian adult healthy participants. The secondary Objective is to assess the safety and tolerability of a single 125 μg subcutaneous (SC) dose of BIIB017 in Japanese and Caucasian adult healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon Beta-1a administered to Japanese participants | Experimental | A single dose of Peginterferon Beta-1a 125 μg subcutaneous (SC) injection administered by pre-filled syringe |
|
| Peginterferon Beta-1a administered to Caucasian participants | Experimental | A single dose of Peginterferon Beta-1a 125 μg subcutaneous (SC) injection administered by pre-filled syringe |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon Beta-1a | Biological | As specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time zero to infinity (AUC0-∞) | Up to 240 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) of Peginterferon Beta-1a | Up to 240 hours post-dose | |
| Number of participants that experience adverse events (AEs) and serious adverse events (SAEs) | Up to Day 29 |
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Key Inclusion Criteria:
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 | Leeds | West Yorkshire | LS2 9LH | United Kingdom |
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| ID | Term |
|---|---|
| C428112 | peginterferon beta-1a |
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