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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004560-11 | EudraCT Number |
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The primary objective of this study is to assess the safety and tolerability of a single dose and multiple doses of BIIB033 administered to healthy adult Japanese participants. The secondary objectives of this study are to evaluate the pharmacokinetics (PK) profile of BIIB033 administered as single and multiple doses in healthy adult Japanese participants and to assess the single-dose and multiple-dose immunogenicity of BIIB033.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | A single IV dose of 10 mg/kg BIIB033 or placebo given on Day 1 |
|
| Cohort 2 | Experimental | A single IV dose of 30 mg/kg BIIB033 or placebo given on Day 1 |
|
| Cohort 3 | Experimental | One IV dose of 100 mg/kg BIIB033 or placebo given on Days 1 and 15 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB033 | Biological | single or multiple dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to day 113 | |
| Number of participants with clinically significant laboratory parameters | Up to day 113 | |
| Number of participants with clinically significant vital sign abnormalities | Up to day 113 | |
| Number of participants with clinically significant electrocardiograms (ECGs) abnormalities | Up to day 113 | |
| Number of participants with clinically significant physical examination abnormalities | Up to day 113 | |
| Number of participants with clinically significant neurological examination abnormalities | Up to day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter of BIIB033: Area under the concentration-time curve from time zero to infinity (AUCinf) | Up to day 113 | |
| PK parameter of BIIB033: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast) | Up to day 113 |
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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 |
|---|---|
| D003711 | Demyelinating Diseases |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D001327 | Autoimmune Diseases |
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| ID | Term |
|---|---|
| C000625770 | opicinumab |
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| Placebo |
| Other |
single or multiple dose |
|
| PK parameter of BIIB033: AUC over a given dosing interval | Up to day 113 |
| PK parameter of BIIB033: Maximum observed concentration (Cmax) | Up to day 113 |
| PK parameter of BIIB033: Time to reach maximum observed concentration (Tmax) | Up to day 113 |
| PK parameter of BIIB033: Terminal elimination half-life (t1/2) | Up to day 113 |
| PK parameter of BIIB033: Volume of distribution at steady state (Vss) | Up to day 113 |
| PK parameter of BIIB033: Clearance (CL) | Up to day 113 |
| PK parameter of BIIB033: accumulation ratio (RAC) | Up to day 113 |
| Number of participants with positive serum BIIB033 antibodies | Up to day 113 |
| D007154 | Immune System Diseases |