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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy volunteers, people with multiple system atrophy (MSA) and people with Parkinson's disease (PD). It tests how safe SST001 is and how the body handles it.
- Age
- Older than 18 years
- Sex
- All sexes can join.
- Disease stage
- MSA: clinically established or clinically probable MSA by the MDS 2022 criteria. PD: clinically established or clinically probable PD by the MDS 2015 criteria. Healthy volunteers: no history of motor or cognitive disorders.
- Earlier treatment
- If MSA or PD was treated before, the treatment must have been stable for at least 4 weeks with no changes planned soon. Prior therapy targeting α-Syn is not allowed.
Main reasons for not taking part
- Pregnant or breastfeeding
- Other severe neurological disorders
- Serious or uncontrolled medical condition
- Active HBV, HCV or HIV infection
- Cannot tolerate PET/CT or MRI, for example because of claustrophobia
Read by machine on 13 November 2026.
Where in China
- Huashan Hospital, Fudan UniversityShanghai, ChinaContact: Jian Wang, ProfessorTaking people
- Affiliated Hospital of Jiangnan UniversityWuxi, ChinaContact: Jing Chun Yu, ProfessorTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.