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| ID | Type | Description | Link |
|---|---|---|---|
| ALXN2230-HV-101 | Registry Identifier | Alexion |
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The primary objective of this study is to evaluate the safety and tolerability of single subcutaneous (SC) doses of ALXN2230 in healthy participants.
Part A of this study is expected to enroll approximately 40 participants (30 on ALXN2230 and 10 on placebo) across 5 cohorts and Part B is expected to enroll approximately 8 participants (6 on ALXN2230 and 2 on placebo) in 1 cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will be enrolled across multiple cohorts and will receive a single dose of placebo. |
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| ALXN2230 | Experimental | Participants will be enrolled across multiple cohorts and will receive a single dose of ALXN2230. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN2230 | Drug | Participants will receive ALXN2230 via SC injection. Optional cohort will receive ALXN2230 via SC infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Day 1 up to Day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of ALXN2230 | Day 1 up to Day 113 | |
| Time to Cmax (Tmax) of ALXN2230 | Day 1 up to Day 113 | |
| Area Under the Concentration-time Curve from Time 0 to the Last Quantifiable Concentration (AUCt) of ALXN2230 |
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Inclusion Criteria:
Exclusion Criteria:
Additional inclusion/exclusion criteria may apply, per protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. (Sponsor) | Contact | 1-855-752-2356 | clinicaltrials@alexion.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | London | NW10 7EW | United Kingdom |
Alexion has a public commitment to allow requests for access to study data and will be supplying a CSR synopsis and plain language summaries.
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| Placebo | Drug | Participants will receive placebo via SC injection. Optional cohort will receive placebo via SC infusion. |
|
| Day 1 up to Day 113 |
| Serum Concentration of Biomarkers | Day 1 up to Day 113 |