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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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This study is designed to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of ALXN2080 in healthy adult participants.
Participants will be assigned to 10 different cohorts (6 SAD cohorts and 4 MAD cohorts), each with 8 participants on active treatment with ALXN2080 and 2 participants on placebo. ALXN2080 will be administered under fasted conditions throughout this study, except for the last SAD Cohort 6 in which ALXN2080 will be given with food to evaluate the effect of food on the single-dose pharmacokinetics of ALXN2080.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD - Cohort 1 | Experimental | Eight participants will receive a single dose of Dose Amount 1 of ALXN2080, and 2 participants will receive placebo. |
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| SAD - Cohort 2 | Experimental | Eight participants will receive a single dose of Dose Amount 2 of ALXN2080, and 2 participants will receive placebo. |
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| SAD - Cohort 3 | Experimental | Eight participants will receive a single dose of Dose Amount 3 of ALXN2080, and 2 participants will receive placebo. |
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| SAD - Cohort 4 | Experimental | Eight participants will receive a single dose of Dose Amount 4 of ALXN2080, and 2 participants will receive placebo. |
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| SAD - Cohort 5 | Experimental | Eight participants will receive a single dose of Dose Amount 5 of ALXN2080, and 2 participants will receive placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN2080 | Drug | Powder-in-capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Day 1 through up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) Of Single Dose ALXN2080 | Up to 168 hours postdose | |
| Maximum Observed Plasma Concentration (Cmax) of Single Dose ALXN2080 | Up to 168 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Belfast | BT9 6AD | 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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| SAD - Cohort 6 | Experimental | Eight participants will receive a single dose of Dose Amount 6 of ALXN2080, and 2 participants will receive placebo. |
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| MAD - Cohort 1 | Experimental | Eight participants will receive multiple doses of Dose Amount A of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days. |
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| MAD - Cohort 2 | Experimental | Eight participants will receive multiple doses of Dose Amount B of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days. |
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| MAD - Cohort 3 | Experimental | Eight participants will receive multiple doses of Dose Amount C of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days. |
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| MAD - Cohort 4 | Experimental | Eight participants will receive multiple doses of Dose Amount D of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days. |
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| Placebo | Drug | Powder-in-capsule |
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