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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This is a randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety and tolerability of Intravenous (IV) and Subcutaneous (SC) REGN1033(SAR391786) in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Dose regimen 1 (Participants 18 to ≤ 65 yrs old) |
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| Cohort 2 | Experimental | Dose regimen 2 (Participants 18 to ≤ 65 yrs old) |
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| Cohort 3 | Experimental | Dose regimen 3 (Participants 18 to ≤ 65 yrs old) |
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| Cohort 4 | Experimental | Dose regimen 4 (Participants 18 to ≤ 65 yrs old) |
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| Cohort 5 | Experimental | Dose regimen 5 (Participants 18 to ≤ 65 yrs old) |
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| Cohort 6 | Experimental | Dose regimen 6 (Participants 18 to ≤ 65 yrs old) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN1033(SAR391786) | Drug | Administration method A |
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| 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 subjects treated with REGN1033 or placebo, reported from the time of administration of study drug on day 1 (baseline) to completion of the study (day 113). | Day 1 to Day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration | To characterize the pharmacokinetic (PK) profile (i.e. serum concentration) of IV and SC doses of REGN1033. | Baseline to End of Study (Day 113) |
| Immunogenicity | To assess the potential for immunogenicity following IV and SC doses of REGN1033. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honolulu | Hawaii | United States | ||||
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| Cohort 7 | Experimental | Dose regimen 7 (Participants 18 to ≤ 65 yrs old) |
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| Cohort 8 | Experimental | Dose regimen 3 (Participants > 65 to ≤ 85 yrs old) |
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| Cohort 9 | Experimental | Dose regimen 9 (Participants 18 to ≤ 65 yrs old) |
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| REGN1033(SAR391786) | Drug | Administration method B |
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| Placebo | Drug | (inactive substance) |
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| Baseline to End of Study (Day 113) |
| Evansville |
| Indiana |
| 47710 |
| United States |