Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR153191-P3 drug product · 1 trial · 1 indication
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...
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SAR153191-P3 drug product is an investigational small molecule being developed by Sanofi for the treatment of Rheumatoid Arthritis. It is currently in Phase 1 clinical development, meaning it is still being studied and is not yet approved for use.
The molecular target of SAR153191-P3 drug product has not been disclosed. It is a small molecule being developed for Rheumatoid Arthritis, but its specific mechanism of action is not publicly available.
SAR153191-P3 drug product is developed by Sanofi, a global biopharmaceutical company. Sanofi is publicly traded under the ticker symbol SNY.
SAR153191-P3 drug product is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
SAR153191-P3 drug product has one completed clinical trial, NCT06159452, which studied the tolerability of different SAR153191 drug products in healthy male subjects. The trial enrolled 53 participants and was a randomized, double-blind, active-controlled study.
SAR153191-P3 drug product is a specific formulation of the SAR153191 drug product. The trial NCT06159452 evaluated different SAR153191 drug products that differ in manufacturing processes and formulation, with SAR153191-P3 being one of the tested versions.