Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06159452 | Study of the Tolerability of Different SAR153191 Drug Products, That Differ With Respect to Manufacturing Processes and Formulation, at Different Concentrations and Doses in Healthy Male Subjects | PHASE1 | COMPLETED | 53 | — | — | Jul 9, 2010 | Dec 21, 2010 | Dec 6, 2023 | - | — |
Injection site reactions include pain, erythema an edema.
| Arm | Type | Description |
|---|---|---|
| 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 |
| Group E' | ACTIVE_COMPARATOR | SAR153191 - CIF3 drug product concentration 2 dose 3 |
| Name | Type | Description |
|---|---|---|
| SAR153191-P3 drug product | DRUG | Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection |
| 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 |
Inclusion Criteria: * Having given written informed consent prior to any procedure related to the study. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Any subject who, in the judgment of the Investigator, is likely to be noncompliant during t...