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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1120-0670 | Other Identifier | UTN |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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Primary Objective:
Injection Site Tolerability
Secondary Objectives:
Total duration for each subject (not including screening) will be approximately 85 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alirocumab SAR236553 (REGN727) (Formulation A x 1) | Experimental | A single subcutaneous injection of Formulation A |
|
| alirocumab SAR236553 (REGN727) (Formulation B x 1) | Experimental | A single subcutaneous injection of Formulation B |
|
| alirocumab SAR236553 (REGN727) (Formulation A x 2) | Experimental | 2 single subcutaneous injections of Formulation A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alirocumab SAR236553 (REGN727) | Drug | Pharmaceutical form:solution Route of administration: subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain using Present Pain Intensity (PPI) verbal questionnaire and Visual Analog Scale (VAS) | 15 days | |
| Erythema at injection site by measuring diameter and qualitative assessment | 15 days | |
| Edema at injection site by measuring diameter and qualitative assessment | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of PK parameter - time to maximum concentration (tmax) | Up to 85 days | |
| Pharmacodynamics: Change in LDL-C from baseline | Up to 85 days | |
| Number of participants with Adverse Events |
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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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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | United States |
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| Up to 85 days |
| Assessment of PK parameter - maximum concentration (Cmax) | Up to 85 days |
| Assessment of PK parameter - area under curve (AUC) | Up to 85 days |
| Assessment of PK parameter - area under curve versus time curve (AUC0-D29) | Zero to Day 29 |
| Assessment of PK parameter - plasma concentration on Day 29 (C D29) | Day 29 |
| Assessment of PK parameter - terminal elimination half-life (t1/2z) | Up to 85 days |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C571059 | alirocumab |
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