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The primary objective of this study is to characterize the PK properties of a single dose of gefurulimab in healthy Chinese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gefurulimab | Experimental | Participants will receive a single SC dose of gefurulimab in the abdomen on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gefurulimab | Drug | Participants will receive gefurulimab subcutaneously (SC). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of Gefurulimab | Day 1 predose through Day 92 postdose | |
| Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Gefurulimab | Day 1 predose through Day 92 postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Free Complement Component 5 (C5) Concentration | Day 1 predose through Day 92 postdose | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Day 1 through Day 92 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Shanghai | 201107 | China |
Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
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| Number of Participants With Anti-drug Antibodies (ADAs) | Day 1 through Day 92 |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Associated With Prefilled Syringe With Needle Safety Device (PFS-SD) | Day 1 through Day 92 |
| Number of Participants With Successful and Failed Dose Administrations | Day 1 through Day 92 |