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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1293-6227 | Registry Identifier | ICTRP |
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Primary objective:
To determine the tolerability of different SAR153191 drug products that differ with respect to manufacturing processes and formulation, at different concentrations and doses, after administration of single subcutaneous doses to healthy male subjects.
Secondary objectives:
To determine the pharmacokinetic profile of the different SAR153191 drug products administered subcutaneously.
To assess the safety of the different SAR153191 drug products administered subcutaneously.
Up to 35 Days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | SAR153191 - P3 drug product concentration 1 dose 1 |
|
| Group B | Experimental | SAR153191 - P2 drug product concentration 2 dose 2 |
|
| Group C | Experimental | SAR153191 - P3 drug product concentration 2 dose 2 |
|
| Group D | Experimental | SAR153191 - P3 drug product concentration 3 dose 3 |
|
| Group B' | Experimental | SAR153191 - P2 drug product concentration 2 dose 3 |
|
| Group C' | Experimental | SAR153191 - P3 drug product concentration 2 dose 3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR153191-P3 drug product | Drug | Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reporting injection site reactions | Injection site reactions include pain, erythema an edema. | At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21, and 35 following SAR153191 administration |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Cmax | Maximum plasma concentration observed | At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration |
| Pharmacokinetics: tmax | First time to reach Cmax |
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Inclusion 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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| Group E' | Active Comparator | SAR153191 - CIF3 drug product concentration 2 dose 3 |
|
|
| SAR153191-P2 drug product | Drug | Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection |
|
|
| SAR153191-C1F3 drug product | Drug | Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection |
|
|
| At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration |
| Pharmacokinetics: AUClast | Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time | At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration |
| Pharmacokinetics: AUC | Area under the plasma concentration versus time curve extrapolated to infinity | At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration |
| Pharmacokinetics: t1/2z | Terminal half-life associated with the terminal slope (λz) | At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration |
| Safety: Number of participants who experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment-Emergent Adverse Events of Special Interest (AESI) | Up to 35 Days |
| Incidence of anti-SAR153191 antibodies | At Day 1 predose and on Days 7, 21, and 35 (plus follow-up if positive) |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000592401 | sarilumab |
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