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Humanized anti-Factor Bb monoclonal antibody

Phase 1

Paroxysmal Nocturnal Hemoglobinuria | Small molecule | Other |Sanofi|Last Updated: Mar 22, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06326814A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy AdultsPHASE1 COMPLETED 54 — — Oct 11, 2021May 5, 2023Mar 22, 20242 United States
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Study Endpoints
Primary Endpoints
Number of participants with adverse events (AEs)/treatment-emergent adverse events (TEAEs)
Baseline up to 23 weeks
Incidence of potentially Clinical laboratory abnormalities
Baseline up to 23 weeks
Secondary Endpoints
PK parameters of SAR443809 for IV and SC administrations: Maximum plasma concentration observed (Cmax
Baseline up to 23 weeks
PK parameters of SAR443809 for IV and SC administrations: First time to reach Cmax (tmax
Baseline up to 23 weeks
PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to tlast (AUClast)
Baseline up to 23 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SAR443809 and placebo dose 1 ArmEXPERIMENTAL6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 1
SAR443809 and placebo dose 2 ArmEXPERIMENTAL6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 2
SAR443809 and placebo dose 3 ArmEXPERIMENTAL6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 3
SAR443809 and placebo dose 4 ArmEXPERIMENTAL6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 4
SAR443809 and placebo dose 5 ArmEXPERIMENTAL6 participants receiving SAR443809 and 2 receiving placebo, subcutaneous administration dose 5
SAR443809 and placebo dose 6 ArmEXPERIMENTALOptional: 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 6
SAR443809 and placebo dose 7 ArmEXPERIMENTALOptional: 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 7
Interventions
NameTypeDescription
Humanized anti-Factor Bb monoclonal antibodyDRUGPharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
PlaceboDRUGPharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites2

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...

Countries:United States
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