Phase I Open-Label Study to Assess Safety, Tolerability, and Pharmacokinetics of SST001 PET Tracer in Healthy Adults and Patients with Parkinsons Disease or Multiple System Atrophy

What this Trial Is About

Researchers are studying SST001, a PET tracer labeled with 18F, which is designed to detect alpha-synuclein pathology seen in Parkinsons Disease PD and Multiple System Atrophy MSA. This phase I, non-randomized, open-label study aims to evaluate the safety, tolerability, biodistribution, radiation dosimetry, and pharmacokinetics of SST001 in healthy volunteers as well as patients with PD and MSA. Participants in this study will receive an administration of SST001 followed by PET imaging to track its distribution and behavior in the body. The study involves a single group design without placebo or comparison arms. The focus is on collecting data on how the tracer distributes in the body, its radiation dose, and how the body processes it. Participants will be monitored for adverse events for 5 days after receiving SST001. Additionally, measurements such as whole body effective radiation dose and standardized uptake value ratio SUVR at about 80 minutes post injection will be assessed. The study includes healthy adults and patients aged 40 years or older, with monitoring of safety, imaging, and pharmacokinetic data throughout the study period.

A Study to Evaluate Satety, Tolerability, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of SST001 in Healthy Volunteers, Patients With PD and Patients With MSA