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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1119-3152 | Other Identifier | UTN |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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Primary Objective:
To determine and compare the pharmacokinetic (PK) profiles of 2 different SAR231893 (REGN668) drug products after administration of a single subcutaneous (SC) dose
Secondary Objective:
To determine and compare the safety and tolerability of the 2 SAR231893 (REGN668) drug products after administration of a single SC dose
The duration of the study for each subject is 8-11 weeks broken down as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR231893 (REGN668) Drug Product (DP) 1 | Experimental | SAR231893 (REGN668) Drug Product 1 in a single subcutaneous injection |
|
| SAR231893 (REGN668) Drug Product (DP) 2 | Experimental | SAR231893 (REGN668) Drug Product 2 in a single subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR231893 (REGN668) DP1 | Biological | Pharmaceutical form:solution Route of administration: subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of serum concentrations of SAR231893 (REGN668) | Up to 57 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain evaluation at injection site using Visual Analog Scale (VAS) | Up to 8 Days | |
| Erythema at injection site by measuring diameter | Up to 8 Days | |
| Edema at injection site by measuring diameter |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a subject's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840001 | Daytona Beach | Florida | 32117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32348036 | Derived | Li Z, Radin A, Li M, Hamilton JD, Kajiwara M, Davis JD, Takahashi Y, Hasegawa S, Ming JE, DiCioccio AT, Li Y, Kovalenko P, Lu Q, Ortemann-Renon C, Ardeleanu M, Swanson BN. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Dupilumab in Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2020 Aug;9(6):742-755. doi: 10.1002/cpdd.798. Epub 2020 Apr 29. |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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| SAR231893 (REGN668) DP2 | Biological | Pharmaceutical form:solution Route of administration: subcutaneous |
|
| Up to 8 Days |
| Number of participants experiencing adverse events | Up to 57 Days |