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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004500-19 | EudraCT Number |
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This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1720 administered subcutaneously (SC) or intravenously (IV).
Participants will be randomized in a 3:1 ratio to receive the active treatment or placebo.
The study will be conducted in healthy adult participants, including participants of Japanese descent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALXN1720 Single Dose SC | Experimental | Participants will receive a single dose of ALXN1720 SC. |
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| ALXN1720 Multiple Dose SC | Experimental | Participants will receive multiple doses of ALXN1720 SC. |
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| ALXN1720 Single Dose SC + rHuPH20 | Experimental | Participants will receive a single dose of ALXN1720 SC in combination with rHuPH20. |
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| ALXN1720 Single Dose IV | Experimental | Participants will receive a single dose of ALXN1720 IV. |
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| Placebo | Placebo Comparator | Participants will receive Placebo SC or Placebo IV according to their assigned cohort. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN1720 SC | Drug | ALXN1720 will be administered via SC route. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-emergent and Serious Adverse Events (TEAEs, SAEs) | Up to 176 days following the first day of dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV | Up to 176 days following the first day of dosing | |
| Area Under The Concentration-time Curve (AUC) of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV | Up to 176 days following the first day of dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Study Site | London | United Kingdom |
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| ALXN1720 IV | Drug | ALXN1720 will be administered via IV route. |
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| rHuPH20 | Drug | rHuPH20 will be administered via SC route. |
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| Placebo SC | Drug | Placebo will be administered via SC route. |
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| Placebo IV | Drug | Placebo will be administered via IV route. |
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| Change from Baseline in Serum Concentrations of Free Complement Component 5 (C5) | Baseline, 176 days following the first day of dosing |
| Change from Baseline in Serum Concentrations of Total C5 | Baseline, 176 days following the first day of dosing |
| Change from Baseline in Ex Vivo Chicken Red Blood Cell (cRBC) Hemolysis Activity | Baseline, 176 days following the first day of dosing |
| Incidence of Antidrug Antibodies (ADAs) to ALXN1720 | Up to 176 days following the first day of dosing |
| Absolute Bioavailability of ALXN1720 | The absolute bioavailability for ALXN1720 SC will be defined by the ratio of the geometric means for AUC for ALXN1720 SC over ALXN1720 IV after a single dose. | Up to 176 days following the first day of dosing |
| Comparison of Incidence of TEAEs and SAEs Between Healthy Non-Japanese Participants and Participants of Japanese Descent | Up to 176 days following the first day of dosing |
| Comparison of Cmax of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV Between Healthy Non-Japanese Participants and Participants of Japanese Descent | Up to 176 days following the first day of dosing |
| Comparison of AUC of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV Between Healthy Non-Japanese Participants and Participants of Japanese Descent | Up to 176 days following the first day of dosing |
| Comparison of Change from Baseline in Serum Concentrations of Free C5 Between Healthy Non-Japanese Participants and Participants of Japanese Descent | Baseline, 176 days following the first day of dosing |
| Comparison of Change from Baseline in Serum Concentrations of Total C5 Between Healthy Non-Japanese Participants and Participants of Japanese Descent | Baseline, 176 days following the first day of dosing |
| Comparison of Change from Baseline in Serum Concentrations in Ex Vivo cRBC Hemolysis Activity Between Healthy Non-Japanese Participants and Participants of Japanese Descent | Baseline, 176 days following the first day of dosing |
| Comparison of ADAs to ALXN1720 Between Healthy Non-Japanese Participants and Participants of Japanese Descent | Up to 176 days following the first day of dosing |