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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000651-41 | EudraCT Number |
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The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of REGN5069 administered intravenously (IV) and subcutaneously (SC) in healthy male and female participants.
The secondary objectives of the study are to characterize the pharmacokinetics (PK) profile of single IV and SC doses of REGN5069 in healthy participants and assess the immunogenicity of REGN5069 in healthy participants administered single IV or SC doses of REGN5069
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Cohort 1 will receive a single IV dose of REGN5069 or matching placebo |
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| Cohort 2 | Experimental | Cohort 2 will receive a single sequential ascending IV dose of REGN5069 or matching placebo |
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| Cohort 3 | Experimental | Cohort 3 will receive a single sequential ascending IV dose of REGN5069 or matching placebo |
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| Cohort 4 | Experimental | Cohort 4 will receive a single sequential ascending IV dose of REGN5069 or matching placebo |
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| Cohort 5 | Experimental | Cohort 5 will receive a single SC dose of REGN5069 or matching placebo |
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| Cohort 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN5069 | Drug | REGN5069 will be administered by IV infusion or SC injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) | From baseline up to week 36 | |
| Incidence of laboratory abnormalities | As measured by chemistry, hematology and urinalysis | From baseline up to week 36 |
| Incidence of vital signs abnormalties | As measured by heart rate, blood pressure, body temperature and respiratory rate | From baseline up to week 36 |
| Incidence of standard 12-lead electrocardiogram (ECG) abnormalties | As measured by heart rate, PR, complex of Q, R, and S waves [QRS], QT-intervals, and QTc | From baseline up to week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of REGN5069 in serum over time | From baseline up to week 36 | |
| Incidence of anti-drug antibody (ADA) | From baseline up to week 36 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol Inclusion/Exclusion Criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Research Facility | Ghent | B-9000 | Belgium |
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Cohort 6 will receive a single sequential ascending SC dose of REGN5069 or matching placebo |
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| Cohort 7 | Experimental | Cohort 7 will receive a single sequential ascending IV dose of REGN5069 or matching placebo |
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| Placebo | Drug | Placebo-matching REGN5069 |
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