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New treatment option for Multiple System Atrophy (MSA)
Official title A Study to Evaluate Satety, Tolerability, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of SST001 in Healthy Volunteers, Patients With PD and Patients With MSA
ClinicalTrials.gov ID: NCT07604116
What this study is testing
What is SST001?
SST001 is an investigational medicine, being studied as a potential treatment for multiple system atrophy (msa).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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 for healthy volunteers: Good health status; no history of motor disorders or cognitive disorders.
- Additional 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...
- Additional 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...
- 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 treatment clinical studies within 30 days.
- Radiation exposure dose exceeding 50 mSv/year.
- Prior therapy targeting α-Syn.
- Other ineligible conditions for this study.
The study team makes the final eligibility decision.
Where it's taking place
- Wuxi, Jiangsu, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuxi, Jiangsu, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.