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ANX1502

Phase 1

Healthy | Small molecule | Other |Annexon, Inc.|Last Updated: Dec 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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment135
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05521269Dose Study of ANX1502 in Healthy VolunteersPHASE1 COMPLETED 135Jun 27, 2022Nov 19, 2024Dec 27, 20241 Netherlands
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Study Endpoints
Primary Endpoints
Number of Participants with Treatment Emergent Adverse Events (TEAEs) After A Single Dose and Multiple Doses of ANX1502
Day 1 (after dosing) through Day 29
Secondary Endpoints
Plasma ANX1502 and ANX1439 Concentrations After A Single Dose and Multiple Doses of ANX1502
Predose up Day 29
Maximum Observed Plasma Concentration (Cmax) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502
Predose up Day 29
Observed Time to Cmax (Tmax) of ANX1502 and ANX1439 After A Single Dose and Multiple Doses of ANX1502
Predose up to Day 29
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
ANX1502 SADEXPERIMENTALParticipants will be administrated a single oral dose of ANX1502 at various ascending dose levels or matching placebo.
ANX1502 MADEXPERIMENTALParticipants will be administrated multiple oral doses of ANX1502 at various ascending dose levels or matching placebo for 14 days.
Interventions
NameTypeDescription
ANX1502DRUGANX1502 is a prodrug of ANX1439.
PlaceboDRUGPlacebo comparator.
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Must be healthy as determined by medical evaluation including medical history, physical examination, vital signs assessments (including supine blood pressure, supine pulse rate, respiration rate, and temporal body temperature), 12-lead electrocardiogram (ECG), and laborato...

Countries:Netherlands
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