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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
Participants will undergo PET imaging after administration.
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Incidence of Adverse Events
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.
Time frame: 5 days
Whole Body Effective Dose
Whole body effective dose calculated from whole-body PET scans of healthy participants.
Time frame: Approximately 4 hours post injection
Standardized Uptake Value Ratio (SUVR)
SUVR of SST001 in brain regions of interest.
Time frame: Approximately 80 minutes post injection
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