NCT07604116招募中1 期
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
Synusight Biotech (Shanghai) Co., Ltd.2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年6月15日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
SST001
Experimental
Administration of SST001
干预措施: SST001 (Drug)
研究者
研究点 (2)
Loading locations...
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