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Biogen Idec has developed a novel process to manufacture Interferon beta-1a (INFB), the active ingredient of Avonex®, that does not include fetal bovine serum (FBS). This bioequivalence study is being conducted to confirm the pharmacokinetic (PK) and pharmacodynamic (PD) comparability of Interferon beta-1a produced by the currently approved serum-containing process and Interferon beta-1a produced by the new serum-free manufacturing process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Commercial INFB followed by Investigational INFB | Other | Process A (currently-approved manufacturing process involving FBS) first, then Process B (new serum-free manufacturing process, without FBS) |
|
| Investigational INFB followed by Commercial INFB | Other | Process B (new serum-free manufacturing process, without FBS) first, then Process A (currently-approved manufacturing process involving FBS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1a (current approved manufacturing process invloving FBS) | Drug | Single dose of 60 mcg given Intramuscularly (IM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum concentration-time curve (AUC) as a measure of PK. | Subjects will be followed for the duration of the study, 22 days. PK samples will be taken 5 to 60 minutes prior to dosing, and post dose at hours 2, 4, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48, 72, 96 and 168. |
| Measure | Description | Time Frame |
|---|---|---|
| The observed maximum (peak) serum Interferon beta-1a concentration (Cmax) | Subjects will be followed for the duration of the study, 22 days. PK samples will be taken 5 to 60 minutes prior to dosing, and post dose at hours 2, 4, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48, 72, 96 and 168. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Saint Paul | Minnesota | United States |
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|
| Interferon beta-1a (new process, manufactured without FBS) | Drug | Single dose of 60 mcg given Intramuscularly (IM) |
|
| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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