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SAR442501

Phase 1

Osteochondrodysplasia | Small molecule | Other |Sanofi|Last Updated: Aug 27, 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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment76
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05846009A First-in-human Single and Repeated Dose Escalation Study of SAR442501 in Healthy Adults SubjectsPHASE1 COMPLETED 76 — — Nov 18, 2020Jan 12, 2022Aug 27, 20241 United States
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Study Endpoints
Primary Endpoints
Number of participants with adverse events/treatment-emergent adverse events/adverse events of special interest
Baseline up to end of study (EOS) (Day 89)
Secondary Endpoints
Assessment of PK parameter: Maximum observed concentration (Cmax)
Baseline up to EOS (Day 89)
Assessment of PK parameter: First time to reach Cmax (tmax)
Baseline up to EOS (Day 89)
Assessment of PK parameter: Partial area under the serum concentration time curve (AUC)
Baseline up to EOS (Day 89)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SAR442501EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
SAR442501DRUGSubcutaneous injection
PlaceboDRUGSubcutaneous injection
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female participants, between 18 and 45 years of age, inclusive. * Body weight between 50.0 and 85.0 kg, inclusive, body mass index between 18.0 and 32.0 kg/m2, inclusive. * Certified as healthy by a comprehensive clinical assessment. * Having given written informed co...

Countries:United States
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