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PRX019

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

PRX019 · 1 trial · 1 indication

Phase 1 1
NCT06699680Phase 1 Study of PRX019 in Healthy Adult VolunteersHealthy Participants Study
COMPLETED50 Analytics
PHASE1COMPLETED
Phase 1 Study of PRX019 in Healthy Adult Volunteers
Healthy Participants StudyUnlock trial analytics

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 to 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)

MEDIUMJun 14, 2026NCT06699680TRIAL_REMOVED: changed
MEDIUMJun 14, 2026NCT06699680TRIAL_REMOVED: changed
MEDIUMJun 14, 2026NCT06699680TRIAL_REMOVED: changed

Frequently asked questions about PRX019

What is PRX019?

PRX019 is an investigational small molecule being developed by Prothena Corporation plc. It is currently in Phase 1 clinical development. A Phase 1 study of PRX019 in healthy adult volunteers has been completed, with 50 participants enrolled.

What is PRX019 used for?

PRX019 is being studied in healthy participants as part of a Phase 1 clinical trial. The study is designed to evaluate the drug in healthy adult volunteers, and the specific therapeutic indication has not been established yet.

Who makes PRX019?

PRX019 is developed by Prothena Corporation plc, a biopharmaceutical company. Prothena is publicly traded on the Nasdaq under the ticker symbol PRTA.

What phase is PRX019 in?

PRX019 is in Phase 1 clinical development. A Phase 1 study of PRX019 in healthy adult volunteers has been completed, with 50 participants enrolled.

What clinical trials is PRX019 in?

PRX019 has one completed Phase 1 clinical trial, identified as NCT06699680. This study, titled 'Phase 1 Study of PRX019 in Healthy Adult Volunteers,' enrolled 50 participants in the United States and was a randomized, double-blind, controlled trial.

Is PRX019 FDA approved?

PRX019 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A Phase 1 study in healthy volunteers has been completed, but the drug has not yet been approved for any use.