SST001 PET tracer safety and pharmacokinetics in healthy adults and people with PD or MSA

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-randomized, open-label phase 1 trial designed to evaluate safety, tolerability, biodistribution, radiation dose, and pharmacokinetics of the 18F-labeled SST001 tracer. The study includes healthy volunteers as well as participants with Parkinson’s disease and those with multiple system atrophy. SST001 targets alpha-synuclein pathology in vivo, aiming to aid future imaging of disease processes. Methods involve serial imaging and blood sampling to characterize how the tracer distributes, clears, and what radiation exposure it delivers. The trial is primarily exploratory and foundational, informing safer and more effective use in later studies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 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.

Where it's running

• Affiliated Hospital of Jiangnan University
  Wuxi, Jiangsu, China Recruiting
• Huashan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jian Wang, Professor
• Email: wangjian336@hotmail.com
• Phone: +86 021-52888163

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.