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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005005-40 | |||
| U1111-1134-2618 | Other Identifier | UTN |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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Primary Objective:
To assess the relative bioavailability of a single subcutaneous dose of alirocumab SAR236553 (REGN727) administered at 3 different injection sites in healthy subjects.
Secondary Objectives:
Total duration of the study per subject is about 15 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alirocumab SAR236553 (REGN727) - Dose A | Experimental | alirocumab SAR236553 (REGN727) - Dose A - Injection in healthy subjects through subcutaneous administration in the abdomen. alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9) |
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| alirocumab SAR236553 (REGN727) - Dose B | Experimental | alirocumab SAR236553 (REGN727) - Dose B - Injection in healthy subjects through subcutaneous administration in the upper arm. |
|
| alirocumab SAR236553 (REGN727) - Dose C | Experimental | alirocumab SAR236553 (REGN727) - Dose C - Injection in healthy subjects through subcutaneous administration in the thigh. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alirocumab SAR236553 (REGN727) | Drug | Pharmaceutical form:Solution for injection Route of administration: Subcutaneous |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the serum concentrations of alirocumab SAR236553 (REGN727) after a single subcutaneous administration at 3 different injection sites in healthy subjects as a measure of the pharmacokinetics of this investigational medicinal product. | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the serum concentrations of low-density lipoprotein cholesterol after a single subcutaneous administration of alirocumab SAR236553 (REGN727) as a measure of the pharmacodynamic effect of this investigational medicinal product. | Up to 12 weeks | |
| Assessment of the number of subjects with adverse events after a single subcutaneous administration of alirocumab SAR236553 (REGN727) as a measure of the safety/tolerability of this investigational medicinal product. |
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Inclusion criteria:
Healthy subjects.
Exclusion criteria:
Healthy subjects with history or presence of clinically relevant illness.
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 |
|---|---|---|---|---|---|---|
| Investigational Site Number 826001 | London | NW10 7EW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25256660 | Derived | Lunven C, Paehler T, Poitiers F, Brunet A, Rey J, Hanotin C, Sasiela WJ. A randomized study of the relative pharmacokinetics, pharmacodynamics, and safety of alirocumab, a fully human monoclonal antibody to PCSK9, after single subcutaneous administration at three different injection sites in healthy subjects. Cardiovasc Ther. 2014 Dec;32(6):297-301. doi: 10.1111/1755-5922.12093. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C571059 | alirocumab |
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| Up to 12 weeks |
| Assessment of the serum concentration of anti-drug antibodies after a single subcutaneous dose of alirocumab SAR236553 (REGN727) as a measure of the immunogenicity of this investigational medicinal product. | Up to 12 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |