A Study to Evaluate Satety, Tolerability, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of SST001 in Healthy Volunteers, Patients With PD and Patients With MSA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SST001.
- Who it may be relevant to
- Registry conditions: Multiple System Atrophy (MSA), Parkinson's Disease (PD). Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
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.
Detailed 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.
Interventions
- Drug SST001
Participants will undergo PET imaging after administration.
Primary outcome measures
- Incidence of Adverse Events [Time frame: 5 days]
Secondary outcome measures (2)
- Whole Body Effective Dose [Time frame: Approximately 4 hours post injection]
- Standardized Uptake Value Ratio (SUVR) [Time frame: Approximately 80 minutes post injection]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 2 centers
- Affiliated Hospital of Jiangnan University — Wuxi
- Huashan Hospital, Fudan University — Shanghai
Identifiers
NCT: NCT07604116 · SST001-CP101