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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...
Humanized anti-Factor Bb monoclonal antibody, also known as SAR443809, is being developed for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH), a rare blood disorder. It is currently in Phase 1 clinical development and is being studied for its safety and tolerability in healthy adults.
Humanized anti-Factor Bb monoclonal antibody targets Factor Bb, a component of the alternative complement pathway. By binding to Factor Bb, it aims to modulate the complement system, which is implicated in the destruction of red blood cells in Paroxysmal Nocturnal Hemoglobinuria.
Humanized anti-Factor Bb monoclonal antibody is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's safety and tolerability in healthy volunteers.
Humanized anti-Factor Bb monoclonal antibody is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. A Phase 1 trial has been completed to assess its safety and tolerability when administered as a single dose in healthy adults.
Humanized anti-Factor Bb monoclonal antibody has one completed clinical trial, identified as NCT06326814. This Phase 1 study, titled 'A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults,' enrolled 54 participants in the United States and was a randomized, double-blind, controlled trial.
Yes, Humanized anti-Factor Bb monoclonal antibody is also known as SAR443809. The drug is referred to by this alternative name in clinical trial registrations and scientific literature. Both names refer to the same investigational therapy being developed by Sanofi for Paroxysmal Nocturnal Hemoglobinuria.