Multiple System Atrophy (MSA)Phase 1NCT07604116
A Study to Evaluate Satety, Tolerability, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of SST001 in Healthy Volunteers, Patients With PD and Patients With MSA
A Phase 1 study testing SST001 in people with Multiple System Atrophy (MSA) and Parkinson's Disease (PD), run by Synusight Biotech (Shanghai) Co., Ltd. at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple System Atrophy (MSA), Parkinson's Disease (PD)
- What is being tested?
- SST001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 15 Jun 2026to Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Jian Wang, Professor, +86 021-52888163, wangjian336@hotmail.com
- Recruiting
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214122
Jing Chun Yu, Professor, +86 0510-68089401, ycjwxd1978@jiangnan.edu.cn
About this study
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
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.
Read the detailed description
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.
- Being tested
- SST001
- Medical subject headings
- Multiple System Atrophy, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SST001Drug
Participants will undergo PET imaging after administration.
| Study group | Role | What they receive |
|---|---|---|
| SST001 | Experimental | Administration of SST001 Receives: Drug: SST001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Number of participants with adverse events, serious adverse events, physical examination abnormalities, vital sign abnormalities, ECG abnormalities, clinical laboratory abnormalities, injection site reaction after drug injection.
Measured: 5 days
Secondary outcomes (2)
Whole Body Effective Dose
Whole body effective dose calculated from whole-body PET scans of healthy participants.
Measured: Approximately 4 hours post injection
Standardized Uptake Value Ratio (SUVR)
SUVR of SST001 in brain regions of interest.
Measured: Approximately 80 minutes post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start15 Jun 2026
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System Atrophy (MSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synusight Biotech (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604116
- Sponsor's protocol ID
- SST001-CP101
- Status last verified
- Aug 2026
- First submitted
- 17 May 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07604116
- Acronym / sponsor ID
- SST001-CP101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Synusight Biotech (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SST001 | Experimental | Drug: SST001Administration of SST001 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SST001Participants will undergo PET imaging after administration. | Drug | SST001 |
Primary outcome
Incidence of Adverse Events
Time frame: 5 days
Number of participants with adverse events, serious adverse events, physical examination abnormalities, vital sign abnormalities, ECG abnormalities, clinical laboratory abnormalities, injection site reaction after drug injection.
2 secondary outcomes
Whole Body Effective Dose
Time frame: Approximately 4 hours post injection
Standardized Uptake Value Ratio (SUVR)
Time frame: Approximately 80 minutes post injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SST001 in people with Multiple System Atrophy (MSA) and Parkinson's Disease (PD), run by Synusight Biotech (Shanghai) Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Wang, Professor (+86 021-52888163, wangjian336@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.