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PRX019

Phase 1

Healthy Participants Study | Small molecule | Other |Prothena Corporation plc|Last Updated: May 14, 2026

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-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06699680Phase 1 Study of PRX019 in Healthy Adult VolunteersPHASE1 COMPLETED 50Nov 8, 2024Jan 16, 2026May 14, 20261 United States
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Study Endpoints
Primary Endpoints
Number of participants with adverse events
Up to 6 months
Number of participants with clinical laboratory assessment abnormalities
Up to 6 months
Secondary Endpoints
Maximum observed plasma concentration (Cmax)
Up to 6 months
Time to the maximum measured plasma concentration (Tmax)
Up to 6 months
Area under the concentration-time curve from time 0 through the intended dosing interval (AUCͳ)
Up to 6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PRX019, single doseEXPERIMENTALSpecified dose on specified days
PRX019, multiple doseEXPERIMENTALSpecified dose on specified days
Interventions
NameTypeDescription
PRX019DRUGSpecified dose on specified days
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examination, and clinical laboratory tests obtained during the screening period * Participant is willing and able to adhere to the study visit schedule a...

Countries:United States
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Recent Changes (Last 90 Days)
HIGHMay 26, 2026NCT06699680Status: RECRUITING → COMPLETED
LOWMay 24, 2026NCT06699680studyFirstPostDate: changed