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The main goals of this trial are to learn more about a) the safety and tolerability of Lu AF82422 (any new or worsening medical issues the participants have with treatment), b) the immunogenicity of Lu AF82422 (the potential for the drug to trigger an unwanted immune response), and c) the pharmacokinetic parameters of Lu AF82422 (how the drug is absorbed, distributed, and processed by the body). During the trial, healthy adult Chinese and Caucasian participants will receive a single dose of Lu AF82422, which will be given as an intravenous infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AF82422 Dose Level 1 | Experimental | Participants will receive a single intravenous (IV) infusion of Lu AF82422 |
|
| Lu AF82422 Dose Level 2 | Experimental | Participants will receive a single IV infusion of Lu AF82422 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF82422 | Drug | Lu AF82422 solution for intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (safety and tolerability) | Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, blood closure time and ECG parameters) | From Day 1 to Day 140 |
| Number of participants with anti-drug antibodies | From Day 1 to Day 140 | |
| Cmax: maximum observed plasma concentration of Lu AF82422 | From Day 1 to Day 140 | |
| Tmax: time to maximum observed concentration of Lu AF82422 | From Day 1 to Day 140 | |
| AUC0-t: area under the concentration-time curve from zero to time t of Lu AF82422 | From Day 1 to Day 140 | |
| AUCinf: area under the concentration-time curve from zero to infinity of Lu AF82422 | From Day 1 to Day 140 | |
| AUC%extr: percent extrapolated AUC of total AUC0-inf of Lu AF82422 | From Day 1 to Day 140 | |
| AUMC0-inf: area under the first moment concentration-time curve from zero to infinity of Lu AF82422 | From Day 1 to Day 140 | |
| t1/2: apparent terminal elimination half-life of Lu AF82422 | From Day 1 to Day 140 | |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined criteria 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 |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Fudan University | Shanghai | 200032 | China |
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| MRT: mean residence time of Lu AF82422 |
| From Day 1 to Day 140 |
| CL: systemic clearance of Lu AF82422 | From Day 1 to Day 140 |
| t1/2eff: effective elimination half-life of Lu AF82422 | From Day 1 to Day 140 |
| Vz: apparent volume of distribution of Lu AF82422 | From Day 1 to Day 140 |
| Vss: steady-state volume of distribution of Lu AF82422 | From Day 1 to Day 140 |