SST001 for Parkinson's (NCT07604116)
Image Parkinson related brain protein
- Trial ID
- NCT07604116
- Official Title
- 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
- Goal
- Image Parkinson related brain protein
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Synusight Biotech (Shanghai) Co., Ltd.
- Study Type
- INTERVENTIONAL
- Enrollment
- 30 participants
- Conditions
- Multiple System Atrophy (MSA), Parkinson's Disease (PD)
- Interventions
- SST001
Summary For Families
Goal: to find out whether a new brain imaging tracer called SST001 is safe and well tolerated and to learn where it goes in the body, how the body processes it, and what radiation dose it gives. Approach: participants will receive a very small dose of SST001, labeled with fluorine-18, and have positron emission tomography (PET) scans to see if the tracer can detect alpha-synuclein pathology, a hallmark of Parkinson's disease and multiple system atrophy. Eligibility: adults aged 40 and older, including healthy volunteers and people diagnosed with Parkinson's or multiple system atrophy (if on treatment, the regimen must be stable for at least four weeks); common exclusions include pregnancy, serious other medical or neurological problems, active infections, inability to tolerate required scans (for example PET/CT or magnetic resonance imaging), recent interventional trial participation, or prior therapies targeting alpha-synuclein.
Locations
- Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China
- Huashan Hospital, Fudan University, Shanghai, Shanghai Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying SST001. Goal: to find out whether a new brain imaging tracer called SST001 is safe and well tolerated and to learn where it goes in the body, how the body processes it, and what radiation dose it gives. Approach: participants will receive a very small dose of SST001, labeled with fluorine-18, and have positron emission tomography (PET) scans to see if the tracer can detect alpha-synuclein pathology, a hallmark of Parkinson's disease and multiple system atrophy. Eligibility: adults aged 40 and older, including healthy volunteers and people diagnosed with Parkinson's or multiple system atrophy (if on treatment, the regimen must be stable for at least four weeks); common exclusions include pregnancy, serious other medical or neurological problems, active infections, inability to tolerate required scans (for example PET/CT or magnetic resonance imaging), recent interventional trial participation, or prior therapies targeting alpha-synuclein.
- Who can participate?
- Participants must be at least 40 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 6 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.