Safety study of SST001 in Parkinson's disease and multiple system atrophy
Tests SST001 in healthy adults and people with Parkinson's or MSA.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate Satety, Tolerability, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of SST001 in Healthy Volunteers, Patients With PD and Patients With MSA
Key facts
- Where
- Shanghai and Wuxi, ChinaSee the 2 sites
- Phase
- Phase 1
Where in China
- Huashan Hospital, Fudan UniversityShanghai, ChinaTaking people
- Affiliated Hospital of Jiangnan UniversityWuxi, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Synusight Biotech (Shanghai) Co., Ltd.
- Trial code
- NCT07604116
- Record updated
- 1 September 2026
- Original description
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.Read full original descriptionShow less
A Non-Randomized, Open-Label Phase I Study to Evaluate the Safety, Tolerability, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of SST001 in Healthy Volunteers, Patients With Multiple System Atrophy, and Patients With Parkinson's Disease
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.
Inclusion: Sign the informed consent form approved by IEC; Male or female participants aged >18 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: Radiation exposure dose exceeding 50 mSv/year; Prior therapy targeting α-Syn; 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; Other ineligible conditions for this study; Being pregnant or lactating; Intolerance to PET/CT or MRI (e.g. claustrophobia); Any interventional clinical studies within 30 days.