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| ID | Type | Description | Link |
|---|---|---|---|
| 2023- 505041-52-00 | Registry Identifier | EU CT Number |
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The purpose of this study is to learn about the safety and tolerability of different doses of REGN17092 administered with a needle either under the skin (called "subcutaneous") or into a vein (called an "infusion") in healthy participants. This is the first time that REGN17092 will be given to people.
Other aims are to assess:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Mid IV Dose | Experimental | Randomized 6:2 for single ascending dose |
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| Cohort 3 High IV Dose | Experimental | Randomized 6:2 for single ascending dose |
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| Cohort 5 Higher IV Dose | Experimental | Randomized 6:2 for single ascending dose |
|
| Cohort 6 Low IV Dose | Experimental | Randomized 6:2 for single ascending dose |
|
| Cohort 2 Mid SC Dose | Experimental | Randomized 6:2 for single ascending dose |
|
| Cohort 4 High SC Dose | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN17092 | Drug | Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of all treatment emergent adverse events (TEAEs) | Through approximately day 365 | |
| Severity of all TEAEs | Through approximately day 365 | |
| Occurrence of all treatment emergent serious adverse events (TE-SAEs) | Through approximately day 365 | |
| Severity of all TE-SAEs | Through approximately day 365 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of REGN17092 in serum over time | Through approximately day 365 | |
| Incidence of Anti-drug antibodies (ADAs) to REGN17092 over time | Through approximately day 365 | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| UZ Leuven Gasthuisberg Campus | Leuven | 3000 | Belgium |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 1, 2023 | Mar 29, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
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Randomized 6:2 for single ascending dose
|
| Cohort 7 Low SC Dose | Experimental | Randomized 6:2 for single ascending dose |
|
| Expansion Cohort 1 | Experimental | Randomized 3:1 for single ascending dose |
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| Expansion Cohort 2 | Experimental | Randomized 3:1 for single ascending dose |
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| Expansion Cohort 3 | Experimental | Randomized 3:1 for single ascending dose |
|
| Matching Placebo | Drug | Single ascending IV or SC administration per the protocol |
|
| Titer of ADAs to REGN17092 over time |
| Through approximately day 365 |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |