NCT07604116 A Study to Evaluate Satety, Tolerability, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of SST001 in Healthy Volunteers, Patients With PD and Patients With MSA
| NCT ID | NCT07604116 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Synusight Biotech (Shanghai) Co., Ltd. |
| Condition | Multiple System Atrophy (MSA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-06-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-06-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07604116 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Multiple System Atrophy (MSA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07604116 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07604116 currently recruiting?
Yes, NCT07604116 is actively recruiting participants. Contact the research team at wangjian336@hotmail.com for enrollment information.
Where is the NCT07604116 trial being conducted?
This trial is being conducted at Wuxi, China, Shanghai, China.
Who is sponsoring the NCT07604116 clinical trial?
NCT07604116 is sponsored by Synusight Biotech (Shanghai) Co., Ltd.. The trial plans to enroll 30 participants.