NCT07604116RecruitingPhase 1
A Study to Evaluate Satety, Tolerability, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of SST001 in Healthy Volunteers, Patients With PD and Patients With MSA
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
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 17 May 2026
- Start date
- 15 Jun 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Synusight Biotech (Shanghai) Co., Ltd.
- Diseases
- Parkinson disease
- NCT number
- NCT07604116
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 15 Jun 2026 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Radiation exposure dose exceeding 50 mSv/year.
- Prior therapy targeting α-Syn.
Other illness
- 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.
Other
- Being pregnant or lactating.
- Intolerance to PET/CT or MRI (e.g. claustrophobia).
- Any interventional clinical studies within 30 days.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Affiliated Hospital of Jiangnan University Coordinator of this site? Confirm its status | Wuxi | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.