| ID | Type | Description | Link |
|---|---|---|---|
| APB-A1-101 | Other Identifier | AprilBio Co. |
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The main goal of this study is to learn more about the safety of a drug called Lu AG22515. During the trial, healthy adult participants will receive a single dose of Lu AG22515 or a placebo (normal saline solution).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Lu AG22515 | Experimental | Participants will receive a single intravenous (IV) infusion of Lu AG22515. |
|
| Part A: Placebo | Placebo Comparator | Participants will receive a single IV infusion of placebo matching to Lu AG22515. |
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| Part B: Lu AG22515 and Immune System Activator | Experimental | Participants will receive a single IV infusion of Lu AG22515 and a subcutaneous (SC) injection of immune system activator 14 days prior to and 14 days following the start of Lu AG22515 IV infusion. |
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| Part B: Placebo and Immune System Activator | Placebo Comparator | Participants will receive a single IV infusion of placebo matching to Lu AG22515 and an SC injection of immune system activator 14 days prior to and 14 days following the start of placebo IV infusion. |
|
| Part C: Lu AG22515 | Experimental | Participants will receive a single intravenous (IV) infusion of Lu AG22515. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG22515 | Drug | sterile solution for infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From the day of study drug administration (Day 1) up to end of study (Day 113) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Anti-Drug Antibodies (ADAs) | Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113) | |
| Area Under the Concentration-Time Curve From Time 0 to Extrapolated to Infinity (AUC0-inf) of Lu AG22515 | Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113) |
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Inclusion Criteria:
Part C only:
Exclusion Criteria:
Note: 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 |
|---|---|---|---|---|---|---|
| CenExel CNS | Long Beach | California | 90806 | United States | ||
| Frontage Clinical Research Inc |
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| Part C: Placebo | Placebo Comparator | Participants will receive a single IV infusion of placebo matching to Lu AG22515. |
|
| Placebo | Drug | sterile solution for infusion |
|
| Immune System Activator | Drug | sterile powder for injection |
|
| Maximum Observed Plasma Concentration (Cmax) of Lu AG22515 | Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113) |
| Time to Reach Cmax (Tmax) of Lu AG22515 | Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113) |
| Apparent Elimination Half-life (t1/2) of Lu AG22515 | Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113) |
| Apparent Total Serum Clearance (CL) of Lu AG22515 | Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113) |
| Volume of Distribution During the Terminal Elimination Phase (Vz) After IV Administration of Lu AG22515 | Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113) |
| Mean Residence Time (MRT) of Lu AG22515 | Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113) |
| Secaucus |
| New Jersey |
| 07094 |
| United States |