Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease

Inclusion Criteria

• •Hoehn and Yahr stage ≤3.0
• •Ambulatory with or without assistance
• •Sexually active fertile participants and their partners must agree to use medically accepted methods of contraception (such as, hormonal methods, including oral, subcutaneous, and intrauterine; barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 3 months after the last dose of study treatment.
• •Willingness and ability to comply with study procedures
• •If on medications for Parkinson's disease drugs, then medication regimen must be stable for 60 days prior to enrollment
• •Abstention from use of other investigative or non-approved drugs for the duration of the trial
• •For Idiopathic Participants
• •A diagnosis of idiopathic Parkinson's disease confirmed by the presence of bradykinesia plus one or both of the following symptoms: rigidity or resting tremor; and with an abnormal DaTscan consistent with a dopaminergic deficit
• •Age 40 to 75 years
• •Within 5 years of diagnosis of Parkinson's disease
• •For Genetic Subtype Participants
• •A confirmed diagnosis of Parkinson's disease plus a genetic diagnosis consistent with Parkinson's disease, specifically PTEN-induced kinase 1 (PINK1), parkin, Leucine-rich repeat kinase 2 (LRRK2) or other mitochondrial genetic subtype
• •Age 21 to 75 years