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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1290-9387 | Registry Identifier | ICTRP |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetic of 2 different dupilumab drug products in adult healthy volunteers. The duration per participant is up to 11 weeks.
Duration per participant is up to 11 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab drug product 1 | Active Comparator | A single subcutaneous injection on Day 1 |
|
| Dupilumab drug product 2 | Experimental | A single subcutaneous injection on Day 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab (SAR231893) | Drug | injection solution subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum serum concentration of functional dupilumab (Cmax) | Pre-dose on Day 1 up to Day 57 | |
| Time to reach Cmax (Tmax) | Pre-dose on Day 1 up to Day 57 | |
| Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast) | Pre-dose on Day 1 up to Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | Day 1 up to Day 57 | |
| Incidence of anti-dupilumab antibodies (ADA) | Day 1 up to Day 57 |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prism Research-Site Number:840001 | Saint Paul | Minnesota | 55144 | United States |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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