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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

NCT07604116

RecruitingPhase 1

Sponsor: Synusight Biotech (Shanghai) Co., Ltd.

Conditions: Multiple System Atrophy (MSA), Parkinson's Disease (PD)

Interventions: SST001

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.

Locations (2)

Wuxi, Jiangsu, China
Shanghai, Shanghai Municipality, China