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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRA CT NO: 2013-002310-12 |
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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
The primary objective of the study is to evaluate the pharmacokinetic (PK) profile of BIIB019 (Daclizumab High Yield Process; DAC HYP) administered as a single subcutaneous (SC) dose (75 mg or 150 mg) Japanese and Caucasian adult healthy volunteers. The secondary objective of this study in this study population is to assess the safety and tolerability of BIIB019 administered as a single SC dose (75 mg or 150 mg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB019, 75 mg | Experimental | BIIB019 delivered via Subcutaneous Injection |
|
| BIIB019, 150 mg | Experimental | BIIB019 delivered via Subcutaneous Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB019 subcutaneous injection | Biological | participants will be randomized to receive a single subcutaneous injection of BIIB019, 75 mg or 150 mg per dose group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time 0 to infinity (AUCinf) | Up to Day 105 | |
| Maximum observed concentration (Cmax) | Up to Day 105 | |
| Time to reach maximum observed concentration (Tmax) | Up to Day 105 | |
| Terminal elimination half-life (t1/2) | Up to Day 105 | |
| Apparent volume of distribution (Vd/F) | Up to Day 105 | |
| Apparent clearance (CL/F) | Up to Day 105 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Day 105 |
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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 | United Kingdom |
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| ID | Term |
|---|---|
| C000598527 | daclizumab HYP |
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