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This study is researching an experimental drug called REGN13335. This is the first time that REGN13335 will be given to people. This study will enroll healthy adults.
The aim of the study is to see how safe and tolerable REGN13335 is in healthy volunteers.
The study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Cohort 1 Low Dose | Experimental | Randomized as described in the protocol |
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| IV Cohort 2 Mid Dose | Experimental | Randomized as described in the protocol |
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| IV Cohort 3 High Dose | Experimental | Randomized as described in the protocol |
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| IV Cohort 4 Higher Dose | Experimental | Randomized as described in the protocol |
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| IV Cohort 5 Highest Dose | Experimental | Randomized as described in the protocol |
|
| SC Cohort 1 Low Dose | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN13335 | Drug | Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events (TEAE's) through the end of the study (EOS) visit | Baseline to day 113 | |
| Severity of TEAE's through the EOS visit | Baseline to day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of functional REGN13335 in plasma through the EOS visit | Baseline to day 113 | |
| Incidence of anti-drug antibodies (ADA) to single doses of REGN13335 over time | Baseline to day 113 | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator
NOTE: Other Protocol Defined 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 |
|---|---|---|---|---|---|---|
| New Zealand Clinical Research | Christchurch | Canterbury | 8011 | New Zealand |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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Randomized as described in the protocol
|
| SC Cohort 2 High Dose | Experimental | Randomized as described in the protocol |
|
| IV or SC Optional Cohort | Experimental | ≤ Highest IV or SC Dose as described in the protocol Randomized as described in the protocol |
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| Matching Placebo | Drug | Administered IV or SC, sequential ascending single dose |
|
| Titer of ADA to single doses of REGN13335 over time |
| Baseline to day 113 |