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

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 Overview

• Status: Not yet recruiting
• Conditions: Parkinson's Disease (PD); Multiple System Atrophy (MSA)
• Intervention / Treatment: Drug: SST001

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jian Wang, Professor; Phone Number: +86 021-52888163; Email: wangjian336@hotmail.com

Study Locations

• China
  • Jiangsu
    • Wuxi, Jiangsu, China, 214122
      • Affiliated Hospital of Jiangnan University
      • Contact: Jing Chun Yu, Professor; Phone Number: +86 0510-68089401; Email: ycjwxd1978@jiangnan.edu.cn
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Huashan Hospital, Fudan University
      • Contact: Jian Wang, Professor; Phone Number: +86 021-52888163; Email: wangjian336@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion 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 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SST001; Administration of SST001	Drug: SST001; Participants will undergo PET imaging after administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole Body Effective Dose	Whole body effective dose calculated from whole-body PET scans of healthy participants.	Approximately 4 hours post injection
Standardized Uptake Value Ratio (SUVR)	SUVR of SST001 in brain regions of interest.	Approximately 80 minutes post injection

Collaborators and Investigators

• Sponsor: Synusight Biotech (Shanghai) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: May 17, 2026
• First Submitted That Met QC Criteria: May 17, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Parkinson Disease; Multiple System Atrophy
• Other Study ID Numbers: SST001-CP101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No