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RIPK1 inhibitor

Phase 1

Multiple Sclerosis Healthy Subjects | Small molecule | Immunology |Sanofi|Last Updated: Apr 25, 2022

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
UNCONTROLLED
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04982991Single Ascending Dose Study of SAR443820 in Healthy Adult Chinese and Japanese Female and Male ParticipantsPHASE1 COMPLETED 14Aug 5, 2021Oct 11, 2021Apr 25, 20221 United Kingdom
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Study Endpoints
Primary Endpoints
Assessment of pharmacokinetic (PK) parameter: Cmax
Up to day 3

Maximum plasma concentration

Assessment of pharmacokinetic (PK) parameter: AUClast
Up to day 3

Area under the plasma concentration versus time curve from time zero to the real time last

Assessment of pharmacokinetic (PK) parameter: AUC
Up to day 3

Area under the plasma concentration versus time curve

Secondary Endpoints
Assessment of adverse events (AEs)
Up to day 21
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Study Design & Arms
AllocationNA
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SAR443820EXPERIMENTALParticipants will receive a single sequence of 3 different doses of SAR443820 in a total of 3 treatment periods
Interventions
NameTypeDescription
RIPK1 inhibitorDRUGCapsule Oral
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Eligibility Criteria
Age Range20 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: East Asian (Chinese and Japanese) male and/or female participant must be 20 to 55 years of age inclusive, at the time of signing the informed consent. Chinese or Japanese ethnicity, according to the following criteria: Chinese; born in China or ethnic Chinese born outside of C...

Countries:United Kingdom
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