Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to investigate how the body absorbs and get rid of eptinezumab when given directly into a vein in Chinese subjects.
This is an interventional, randomized, open-label, parallel-group, single-dose study investigating the safety, tolerability and pharmacokinetic properties of eptinezumab administered by intravenous (iv) infusion.
The study will consist of 20 healthy Chinese subjects, who will be randomized into two single-dose groups. The two groups will be run in parallel. In Group 1, a total of 10 subjects will receive a single iv infusion of 100 mg eptinezumab on Day 1. In Group 2, a total of 10 subjects will receive a single iv infusion of 300 mg eptinezumab on Day 1.
Safety and tolerability will be assessed throughout the study. Blood samples for plasma quantification of free eptinezumab will be collected from Day 1 to the Completion Visit (Day 84)/Withdrawal Visit.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eptinezumab 100 mg | Experimental |
| |
| Eptinezumab 300 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eptinezumab | Drug | single iv infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-inf) eptinezumab | Area under the plasma concentration-time curve | Day 1 to Day 84 |
| Maximal observed plasma concentration (Cmax) of eptinezumab | Day 1 to Day 84 | |
| Systemic clearance (CL) of eptinezumab | Eptinezumab dose/AUC(0-inf) | Day 1 to Day 84 |
| tmax | Nominal time for the occurrence of Cmax (tmax) | Day 1 to Day 84 |
| Apparent terminal elimination half-life (t½) | Day 1 to Day 84 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| zs-hospital Shanghai | Shanghai | China |
Not provided
| ID | Term |
|---|---|
| C000628361 | eptinezumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided