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Experimental drug: ESK-001

Phase 1

Safety and Tolerability | Small molecule | Other |Alumis Inc.|Last Updated: May 9, 2023

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment49
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05431634Multiple Dose Study to Determine Safety and Tolerability of ESK-001 in Healthy ParticipantsPHASE1 COMPLETED 49 — — May 12, 2022Dec 31, 2022May 9, 20231 United States
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Study Endpoints
Primary Endpoints
Incidence of Adverse Events (AEs)
Up to 14 days

Safety and tolerability

Incidence of Serious Adverse Events (SAEs)
Up to 14 days

Safety and tolerability

Secondary Endpoints
The area under plasma concentration-time curve from time zero extrapolated to last measurable concentration (AUCt) for ESK001 on Day 1 and Day 14
Up to 14 days
The area under the plasma concentration-curve over the dosing interval (AUC(0-τ)) for ESK001 on Day1 and Day 14
Up to 14 days
The observed maximum plasma concentration (Cmax) for ESK001 on Day 1 and Day 14.
Up to 14 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo for ESK-001
Experimental Drug ESK-001EXPERIMENTALExperimental Drug ESK-001
Interventions
NameTypeDescription
Experimental drug: ESK-001DRUGMultiple doses of ESK-001
PlaceboOTHERPlacebo
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participant is a man or woman between the ages of 18 and 60years, inclusive, at the Screening Visit * Participant is healthy as determined by medical history, physical examination, vital signs, and routine laboratory parameters * Other inclusions as specified in the protocol ...

Countries:United States
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