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The purpose of this study is to investigate how eptinezumab enters, moves through and exits the body. Safety and tolerability will also be investigated.
The study will consist of 18 healthy Japanese subjects, divided into two single dose cohorts with 9 subjects in each cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 100 mg eptinezumab | Experimental |
| |
| Cohort 2 300 mg eptinezumab | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eptinezumab | Drug | Eptinezumab - single intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax eptinezumab | maximal observed plasma concentration | From dosing to week 12 |
| AUC(0-t) eptinezumab | area under the plasma concentration-time curve from zero to time t | From dosing to week 12 |
| AUC(0-inf) eptinezumab | area under the plasma concentration-time curve from zero to infinity | From dosing to week 12 |
| Systemic Clearance of eptinezumab | From dosing to week 12 |
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Inclusion Criteria:
Other in- and exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P-One Clinic | Tokyo | Japan |
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| ID | Term |
|---|---|
| C000628361 | eptinezumab |
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| Placebo | Drug | Placebo - single intravenous infusion |
|