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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004208-70 | EudraCT Number |
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To evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses and a multiple dose regimen.
Participants will be randomized to single IV or SC or multiple dose treatment with REGN3918 or matched placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN3918 (Cohorts 1-4 & 6a) | Experimental | Cohorts 1-4 and 6a will receive sequential ascending doses of REGN3918 |
|
| Placebo (Cohorts 1-4 & 6a) | Experimental | Cohorts 1-4 and 6a will receive placebo |
|
| REGN3918 (Cohort 5 & 6b) | Experimental | Cohort 5 and 6b will receive multiple doses of REGN3918 |
|
| Placebo (Cohort 5 & 6b) | Experimental | Cohort 5 and 6b will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN3918 | Drug | Intravenous (IV) or Subcutaneous (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events (TEAEs) | Up to 20 weeks | |
| Severity of TEAEs | Up to 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile of REGN3918; single dose IV and SC | Assessed via serum concentrations of REGN3918 over time; Area under the Curve (AUC) | Up to 20 weeks |
| Pharmacokinetic profile of REGN3918; single dose IV and repeated SC doses |
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Key Inclusion Criteria:
A subject must meet the follow criteria to be eligible for inclusion in the study:
Key Exclusion Criteria:
A subject who meets any of the following criteria will be excluded from the study:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit (CRU) Ltd. | Leeds | LS2 9LH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36494054 | Derived | Devalaraja-Narashimha K, Ehmann PJ, Huang C, Ruan Q, Wipperman MF, Kaplan T, Liu C, Afolayan S, Glass DJ, Mellis S, Yancopoulos GD, Hamilton JD, MacDonnell S, Hamon SC, Boyapati A, Morton L. Association of complement pathways with COVID-19 severity and outcomes. Microbes Infect. 2023 May;25(4):105081. doi: 10.1016/j.micinf.2022.105081. Epub 2022 Dec 7. |
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Double-blinded
| Placebo | Drug | Matching Placebo |
|
Assessed via serum concentrations of REGN3918 over time; peak concentration Cmax
| Up to 20 weeks |
| Pharmacodynamics profile of REGN3918 | Assessed by CH50 assay over time | Up to 20 weeks |
| Pharmacokinetic exploratory analysis | Peak concentration Cmax | Up to 20 weeks |
| Immunogenicity of REGN3918 | Assessed by measurement of anti-drug antibodies (ADA) | Up to 20 weeks |