Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR445229 · 1 trial · 1 indication
Maximum serum concentration observed.
Area under the serum concentration versus time curve calculated using the trapezoidal method from time zero to the real time.
Area under the serum concentration versus time curve extrapolated to infinity.
| Arm | Type | Description |
|---|---|---|
| Group 1 | ACTIVE_COMPARATOR | Participants will receive a single dose of subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled syringe (PFS). |
| Group 2 | EXPERIMENTAL | Participants will receive a single dose subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled pen (PFP). |
| Group 3 | ACTIVE_COMPARATOR | Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFS. |
| Group 4 | EXPERIMENTAL | Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFP. |
| Name | Type | Description |
|---|---|---|
| SAR445229 | COMBINATION_PRODUCT | Single dose |
Inclusion Criteria: * Male and/or female participant, between 18 and 55 years of age, inclusive, at the time of signing the informed consent form (ICF). * Certified as healthy by a comprehensive clinical assessment \[detailed medical history and complete physical examination including neurological ...
SAR445229 is an investigational small molecule being developed by Sanofi. It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers, with one completed clinical trial involving 212 participants.
SAR445229 is being studied for use in healthy volunteers. The completed Phase 1 trial was a bioequivalence study, meaning it compared the delivery of the drug by two different devices. The study did not focus on treating a specific disease.
SAR445229 is being developed by Sanofi, a multinational pharmaceutical company. Sanofi's stock is traded under the ticker symbol SNY. The drug is currently in Phase 1 clinical development.
SAR445229 is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are no active trials currently ongoing. The drug is still in the early stages of clinical investigation.
SAR445229 has one completed clinical trial, identified as NCT07146750. This was a Phase 1 bioequivalence study conducted in the United States, enrolling 212 healthy adult participants. The trial compared the drug delivered by two different devices.
SAR445229 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The only completed trial was a bioequivalence study in healthy volunteers, and the drug has not yet progressed to later-stage trials or regulatory approval.