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Rationale for the Study: Phase 1 pharmacokinetic (PK) data is needed in Chinese and Japanese populations to support future clinical development of BIIB023 in China and Japan.
Study Design: This is a single-dose study to assess the PK, safety, and tolerability of BIIB023 administered intravenously (IV) to adult Chinese, Japanese, and Caucasian healthy volunteers. The Caucasian group is included to allow comparison of PK data from different groups using data from the same study under the same controlled conditions.
Subjects will be in the clinic for 48 hours around the time of dosing and in the study for up to 100 days.
Rationale for the Study: Phase 1 pharmacokinetic (PK) data is needed in Chinese and Japanese populations to support future clinical development of BIIB023 in China and Japan.
Study Design: This is a single-dose, Randomized, Double-Blind, parallel-group study to evaluate the PK, safety, and tolerability of BIIB023 administered intravenously (IV) to adult Chinese, Japanese, and Caucasian healthy volunteers. The Caucasian group is included to allow comparison of PK data from different groups using data from the same study under the same controlled conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chinese Subjects - low dose BIIB023 IV | Experimental |
| |
| Chinese Subjects - high dose BIIB023 IV | Experimental |
| |
| Japanese Subjects - low dose BIIB023 IV | Experimental |
| |
| Japanese Subjects - high dose BIIB023 IV | Experimental |
| |
| Causasian Subjects - low dose BIIB023 IV | Experimental |
| |
| Caucasian Subjects - high dose BIIB023 IV | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB023 - low dose IV Dose | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC of BIIB023 | Participants will be followed for the duration of a study; an expected 71 days | |
| Cmax of BIIB023 | Participants will be followed for the duration of a study; an expected 71 days | |
| Tmax of BIIIB023 | Participants will be followed for the duration of a study; an expected 71 days | |
| Half-life of BIIB023 | Participants will be followed for the duration of a study; an expected 71 days | |
| Volume of distribution of BIIB023 | Participants will be followed for the duration of a study; an expected 71 days | |
| Clearance of BIIB023 | Participants will be followed for the duration of a study; an expected 71 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with Adverse Events as a measure of safety and tolerability | Participants will be followed for the duration of a study; an expected 71 days | |
| Number of patients with Serious Adverse Events as a measure of safety and tolerability | Participants will be followed for the duration of a study; an expected 71 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Melbourne | Victoria | Australia | |||
| Research Site |
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| ID | Term |
|---|---|
| C586995 | BIIB023 |
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| BIIB023 - high dose IV Dose | Drug |
|
| Hong Kong |
| Hong Kong |
| China |