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The primary purpose of this study is to assess the safety and tolerability of single ascending doses of ALXN2030 in healthy participants.
Approximately 48 healthy adult participants (36 participants will be on ALXN2030 and 12 participants will be on placebo) are expected to be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALXN2030 Dose A | Experimental | ALXN2030 will be administered as a single dose. |
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| ALXN2030 Dose B | Experimental | ALXN2030 will be administered as a single dose. |
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| ALXN2030 Dose C | Experimental | ALXN2030 will be administered as a single dose. |
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| ALXN2030 Dose D | Experimental | ALXN2030 will be administered as a single dose. |
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| ALXN2030 Dose E | Experimental | ALXN2030 will be administered as a single dose. |
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| Placebo | Placebo Comparator | Placebo will be administered as a single dose. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN2030 | Drug | ALXN2030 will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Day 1 through through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Days 1 (predose; end of infusion (EOI); and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours post-EOI), 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, and 127 | |
| Time to Maximum Observed Plasma Concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Harrow | HA1 3UJ | United Kingdom |
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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| Placebo | Drug | Placebo will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump. |
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| Days 1 (predose; EOI; and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours post-EOI), 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, and 127 |
| Area Under the Plasma Concentration Versus Time Curve From Time 0 (Dosing) to the Last Quantifiable Concentration (AUCt) | Days 1 (predose; EOI; and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours post-EOI), 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, and 127 |
| Change from Baseline in Plasma Concentration of Complement Component 3 (C3) Protein | Baseline (Day 1) and study completion, an average of 1 year |
| Change from Baseline in Serum Complement Functional Activity | Baseline (Day 1) and Day 127 |
| Number of Participants With Treatment-Emergent Antidrug Antibodies (ADAs) | Days 1 through study completion, an average of 1 year |