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A Study to Evaluate Satety, Tolerability, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of SST001 in Healthy Volunteers, Patients With PD and Patients With MSA

RecruitingPhase 1Ages 18 Years - anyAllSynusight Biotech (Shanghai) Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 ฮฑ-Syn. * Other ineligible conditions for this study.
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What it tests

  • SST001
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Where

2 sites
Affiliated Hospital of Jiangnan University
Wuxi, China
Huashan Hospital, Fudan University
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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