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Also known as SAR443809
Humanized anti-Factor Bb monoclonal antibody · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SAR443809 and placebo dose 1 Arm | EXPERIMENTAL | 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 1 |
| SAR443809 and placebo dose 2 Arm | EXPERIMENTAL | 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 2 |
| SAR443809 and placebo dose 3 Arm | EXPERIMENTAL | 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 3 |
| SAR443809 and placebo dose 4 Arm | EXPERIMENTAL | 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 4 |
| SAR443809 and placebo dose 5 Arm | EXPERIMENTAL | 6 participants receiving SAR443809 and 2 receiving placebo, subcutaneous administration dose 5 |
| SAR443809 and placebo dose 6 Arm | EXPERIMENTAL | Optional: 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 6 |
| SAR443809 and placebo dose 7 Arm | EXPERIMENTAL | Optional: 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 7 |
| Name | Type | Description |
|---|---|---|
| Humanized anti-Factor Bb monoclonal antibody | DRUG | Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration |
| Placebo | DRUG | Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration |
Inclusion Criteria: Having given written informed consent prior to undertaking any study-related procedure Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Any participant who, in the judgment of the Investigator, is likely to be noncompliant duri...
The humanized anti-Factor Bb monoclonal antibody, known as SAR443809, is being developed for paroxysmal nocturnal hemoglobinuria, a rare blood disorder. It is an investigational monoclonal antibody and has been studied in a Phase 1 trial in healthy adult volunteers. It is not yet approved for any indication.
It targets Factor Bb, a fragment of complement Factor B. By binding Factor Bb, the antibody is designed to act on the complement pathway, which is relevant to paroxysmal nocturnal hemoglobinuria. The molecule is a humanized monoclonal antibody developed by Sanofi.
Sanofi is developing the humanized anti-Factor Bb monoclonal antibody, which is also known as SAR443809. Sanofi trades on the Nasdaq under the ticker SNY. The asset is part of Sanofi's hematology pipeline and is currently in Phase 1 clinical development.
The humanized anti-Factor Bb monoclonal antibody, SAR443809, is in Phase 1 development. One Phase 1 trial has been completed. It is an investigational agent and is not FDA approved. The completed study enrolled 54 healthy adult participants in the United States.
The humanized anti-Factor Bb monoclonal antibody has been studied in trial NCT06326814, titled A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults. This completed Phase 1 trial enrolled 54 healthy volunteers in the United States and was randomized, double-blind, and controlled.
Yes, SAR443809 is the development code for the humanized anti-Factor Bb monoclonal antibody. Both names refer to the same Sanofi Phase 1 monoclonal antibody being studied for paroxysmal nocturnal hemoglobinuria. Searches for either name point to the same investigational asset.