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The primary objective of the study is to characterize the pharmacokinetics (PK) of BIIB033-B and to compare the PK profile with that of BIIB033-A in healthy volunteers. Secondary objectives are: To assess the safety and tolerability of BIIB033-A and BIIB033-B; To assess the secondary PK parameters of BIIB033-A and BIIB033-B; To assess the immunogenicity of BIIB033-A and BIIB033-B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB033-A | Experimental | Staggered single dosing schema |
|
| BIIB033-B | Experimental | Staggered single dosing schema |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB033 (opicinumab) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter of BIIB033: Area under the concentration-time curve from time 0 to infinity (AUC0-inf) | Up to Day 89 | |
| PK parameter of BIIB033: Area under the concentration-time curve from time 0 to Day 85 (AUC84d) | Day 85 | |
| PK parameter of BIIB033: Maximum observed concentration (Cmax) | Up to Day 89 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 17 weeks | |
| Number of participants with clinically significant laboratory parameters | Up to 17 weeks |
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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 | Madison | Wisconsin | 53704 | 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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| ID | Term |
|---|---|
| C000625770 | opicinumab |
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| Number of participants with clinically significant vital sign abnormalities | Up to 17 weeks |
| Number of participants with clinically significant electrocardiograms (ECGs) abnormalities | Up to 17 weeks |
| Number of participants with clinically significant physical examination abnormalities | Up to 17 weeks |
| PK parameter of BIIB033: Time to reach maximum observed concentration (Tmax) | Up to Day 89 |
| PK parameter of BIIB033: Terminal elimination half-life (t1/2) | Up to Day 89 |
| PK parameter of BIIB033: Volume of distribution at steady state (Vss) | Up to Day 89 |
| PK parameter of BIIB033: Clearance (CL) | Up to Day 89 |
| Number of participants with presence of anti-BIIB033 antibodies | Pre-dose, Day 22 and Day 85 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |