Overview
The non-randomized, open-label phase I study aims to evaluate the safety, tolerability, biodistribution, radiation dosimetry, and pharmacokinetics of SST001 in healthy volunteers, patients with MSA and patients with PD.
Description
SST001 is a 18F-labeled PET tracer designed to detect alpha-synuclein (α-Syn) pathology in vivo, a hallmark of PD and MSA. The non-randomized, open-label phase I study aims to evaluate the safety, tolerability, biodistribution, radiation dosimetry, and pharmacokinetics of SST001 in healthy volunteers, patients with MSA and patients with PD.
Eligibility
Inclusion Criteria:
- Sign the informed consent form approved by IEC.
- Male or female participants aged ≥40 years old.
- Adequate organ functions.
- Proper contraception methods.
- Willingness to follow the study procedures.
- Additional inclusion criteria for healthy volunteers: Good health status; no history of motor disorders or cognitive disorders.
- Additional inclusion criteria for MSA: Diagnosed with clinically established or clinically probable MSA according to the MDS MSA criteria (2022). If previously treated, the treatment regimen for MSA must have been stable for at least 4 weeks with no planned adjustments in the near term.
- Additional inclusion criteria for PD: Diagnosed with clinically established or clinically probable PD according to the MDS PD criteria (2015). If previously treated, the treatment regimen for PD must have been stable for at least 4 weeks with no planned adjustments in the near term.
Exclusion Criteria:
- Being pregnant or lactating.
- History of other severe neurological disorders.
- History of serious or uncontrolled medical condition.
- Active HBV/HCV/HIV infection, etc.
- History of abuse of drugs or alcohol within 1 year.
- Allergy to the study drug.
- Intolerance to PET/CT or MRI (e.g. claustrophobia).
- Any interventional clinical studies within 30 days.
- Radiation exposure dose exceeding 50 mSv/year.
- Prior therapy targeting α-Syn.
- Other ineligible conditions for this study.
