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The main goal of the study is to learn more about how the body absorbs and eliminates Lu AG09222 after a single dose is injected under the skin. Researchers will also investigate safety and tolerability effects of Lu AG09222 after administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AG09222 Low Dose | Experimental | Participants will receive a single dose of Lu AG09222 by subcutaneous (SC) injection on Day 1. |
|
| Lu AG09222 High Dose | Experimental | Participants will receive a single dose of Lu AG09222 by SC injection on Day 1. |
|
| Placebo | Placebo Comparator | Participants will receive a single dose of placebo matching LU AG0922 by SC injection on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG09222 | Drug | Lu AG09222 will be administered per schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Lu AG09222 Serum Concentration-Time Curve (AUC) From Zero to Infinity (AUC0-inf) | Day 1 (predose) to Day 84 | |
| Maximum Observed Concentration (Cmax) of Lu AG09222 | Day 1 (predose) to Day 84 | |
| Apparent Elimination Half-Life (t½) of Lu AG09222 | Day 1 (predose) to Day 84 | |
| Time to Maximum Observed Concentration (tmax) | Day 1 (predose) to Day 84 | |
| Apparent Total Clearance (CL/F) | Day 1 (predose) to Day 84 | |
| Apparent Volume of Distribution (Vz/F) | Day 1 (predose) to Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Specific Anti-Lu AG09222 Antibodies (Anti-Drug Antibodies [ADA]) | Day 1 (predose) to Day 84 | |
| Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb) | Day 1 (predose) to Day 84 |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | H. Lundbeck A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL International | Glendale | California | 91206 | United States |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo | Drug | Placebo matching to Lu AG09222 will be administered per schedule specified in the arm description. |
|
| D009422 | Nervous System Diseases |