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This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the safety and pharmacokinetics of subcutaneous lebrikizumab in healthy Japanese volunteers. Healthy Japanese and Caucasian volunteers will be randomized to receive a single subcutaneous dose of either lebrikizumab or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lebrikizumab | Drug | Dose-level cohorts receiving single subcutaneous dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events in healthy Japanese subjects | 120 days | |
| Pharmacokinetics in healthy Japanese subjects: Area under the concentration-time curve (AUC) | 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of safety (incidence of adverse events) in healthy Japanese and Caucasian subjects | approximately 5 months | |
| Comparison of pharmacokinetics (AUC) in healthy Japanese and Caucasian subjects | approximately 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honolulu | Hawaii | 96813 | United States |
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| ID | Term |
|---|---|
| C561806 | lebrikizumab |
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| placebo |
| Drug |
single dose subcutaneously |
|