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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This is a study to assess the safety and tolerability of subcutaneously administered REGN1033 (SAR391786) in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Dose 1 of REGN1033 (SAR391786) or Placebo |
|
| Cohort 2 | Experimental | Dose 2 of REGN1033 (SAR391786) or Placebo |
|
| Cohort 3 | Experimental | Dose 3 of REGN1033 (SAR391786) or Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN1033 (SAR391786) | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of TEAEs | The primary endpoint in the study is the incidence and severity of TEAEs (Treatment Emergent Adverse Events) in participants treated with REGN1033 (SAR391786) or placebo, reported from the time of administration of study drug on day 1 (baseline) to day 141 (end of study). | Day 1 to Day 141 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration of REGN1033 (SAR391786) | Serum concentration of REGN1033 (SAR391786) over time | Day 1 to Day 141 |
| immunogenicity | Presence or absence of anti-REGN1033 (SAR391786) antibodies over time (immunogenicity ) |
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Inclusion Criteria:
Eligible subjects are males and females aged 60 years and older with no significant health issues or clinically significant abnormal laboratory values.
A subject must meet the following criteria to be eligible for inclusion in the study:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daytona Beach | Florida | United States | ||||
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| Drug |
|
| Day 1 to Day 141 |
| Evansville |
| Indiana |
| United States |