Multiple System Atrophy (MSA), Parkinson's Disease (PD)
Conditions
Brief summary
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
DRUGSST001
Participants will undergo PET imaging after administration.
Sponsors
Synusight Biotech (Shanghai) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | 5 days | Number of participants with adverse events, serious adverse events, physical examination abnormalities, vital sign abnormalities, ECG abnormalities, clinical laboratory abnormalities, injection site reaction after drug injection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Whole Body Effective Dose | Approximately 4 hours post injection | Whole body effective dose calculated from whole-body PET scans of healthy participants. |
| Standardized Uptake Value Ratio (SUVR) | Approximately 80 minutes post injection | SUVR of SST001 in brain regions of interest. |
Countries
China
Contacts
CONTACTJian Wang, Professor
Outcome results
None listed