Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002181-33 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of the study is to evaluate the safety and tolerability of REGN14284 in healthy participants, as measured by all treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs).
The secondary objectives of the study are:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Mid IV Dose | Experimental | Randomized 3:1 for single ascending dose |
|
| Cohort 2 Mid SC Dose | Experimental | Randomized 3:1 for single ascending dose |
|
| Cohort 3 High IV Dose | Experimental | Randomized 3:1 for single ascending dose |
|
| Cohort 4 High SC Dose | Experimental | Randomized 3:1 for single ascending dose |
|
| Cohort 5 Higher IV Dose | Experimental | Randomized 3:1 for single ascending dose |
|
| Cohort 6 Highest IV Dose | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN14284 | Drug | Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence and severity of all treatment emergent adverse events (TEAEs) | Through approximately day 169 | |
| Occurrence and severity of all severe adverse events (SAEs) | Through approximately day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of REGN14284 in serum over time | Through approximately day 169 | |
| Incidence of Anti-drug antibodies (ADAs) to REGN14284 over time | Through approximately day 90 | |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion / exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Leuven Gasthuisberg Campus | Leuven | B-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
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized 3:1 for single ascending dose
|
| Cohort 7 Low IV Dose | Experimental | Randomized 3:1 for single ascending dose |
|
| Cohort 8 Low SC Dose | Experimental | Randomized 3:1 for single ascending dose |
|
| Matching Placebo | Drug | Single ascending IV or SC administration per the protocol |
|
| Titer of ADAs to REGN14284 over time |
| Through approximately day 90 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |