A Study to Evaluate Satety, Tolerability, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of SST001 in Healthy Volunteers, Patients With PD and Patients With MSA
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
1 other identifier
interventional
30
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2026
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2026
CompletedFirst Posted
Study publicly available on registry
May 22, 2026
CompletedStudy Start
First participant enrolled
June 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
June 30, 2026
May 1, 2026
6 months
May 17, 2026
June 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
5 days
Secondary Outcomes (2)
Whole Body Effective Dose
Approximately 4 hours post injection
Standardized Uptake Value Ratio (SUVR)
Approximately 80 minutes post injection
Study Arms (1)
SST001
EXPERIMENTALAdministration of SST001
Interventions
Eligibility Criteria
You may qualify 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 may not qualify 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214122, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2026
First Posted
May 22, 2026
Study Start
June 15, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
June 30, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share