Recent Updates
Recently added Catalysts

PRX019

Phase 1

Undisclosed | Small molecule | Other |Prothena Corporation plc|Trials Updated: May 14, 2026

PRX019 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2024

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

PRX019 clinical trials

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about PRX019

What is PRX019?

PRX019 is an investigational small molecule being developed by Prothena Corporation plc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United States. The specific disease or condition it is intended to treat has not been publicly disclosed.

Who makes PRX019?

PRX019 is being developed by Prothena Corporation plc, which trades on the Nasdaq under the ticker symbol PRTA. Prothena is the sponsor of the clinical program for this investigational small molecule.

What phase is PRX019 in?

PRX019 is in Phase 1 clinical development. Its single reported trial, a Phase 1 study in healthy adult volunteers, has been completed. PRX019 is investigational and has not been approved by the FDA for any indication.

What clinical trials is PRX019 in?

PRX019 has been evaluated in one clinical trial, NCT06699680, titled Phase 1 Study of PRX019 in Healthy Adult Volunteers. The trial enrolled 50 participants in the United States, was randomized, double-blind, and controlled, and its status is completed.

What is PRX019 used for?

The therapeutic use of PRX019 has not been disclosed. It is an investigational small molecule that has completed a Phase 1 study in healthy adult volunteers, and no patient indication has been publicly announced for the program.

Who can participate in PRX019 trials?

The completed Phase 1 study of PRX019, NCT06699680, enrolled healthy adult volunteers aged 18 years and older of any sex in the United States. It was a randomized, double-blind, controlled study with 50 participants.