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Clinical Trial Summary

This study is to investigate the safety and efficacy of PXS-4728A as an intervention therapy in participants with iRBD. This study will be conducted in participants aged 50 to 80 years of age and will investigate a single dose level.


Clinical Trial Description

Up to 48 participants are planned to be screened and approximately 40 participants are planned to be enrolled in this study. Participants will be randomized to receive either active IP or matching placebo in a ratio of 3:1 (30 active and 10 placebo). Study participation will consist of a Screening period of up to 2 weeks to confirm participant eligibility. Once confirmed as eligible, participants will be able to enroll in the study and will be required to attend the clinical site on Day 1 for treatment assignment, initial dosing, and Baseline assessments. Oversight of the study will be provided by a Data Safety Monitoring Committee (DSMC) comprising the Principal Investigator (PI), the local Medical Monitor (MM), and a representative of the Sponsor, at a minimum. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05904717
Study type Interventional
Source Pharmaxis
Contact Jennifer Maschmann
Phone +61 3 9960 7940
Email Jennifer.Maschmann@novotech-cro.com
Status Recruiting
Phase Phase 2
Start date November 8, 2023
Completion date January 31, 2025

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