ClinicalTrials.gov record NCT07604116

A Study to Evaluate Satety, Tolerability, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of SST001 in Healthy Volunteers, Patients With PD and Patients With MSA

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 7, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old and older
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase I, non-randomized, open-label study evaluates SST001—an 18F PET tracer—in healthy volunteers and people with Parkinson's disease (PD) or multiple system atrophy (MSA). It measures safety and tolerability, how the tracer distributes in the body, radiation dose, and basic pharmacokinetics. Participants receive SST001 and undergo PET imaging with short-term safety monitoring.

What it is studying. The study is testing the safety, tolerability, biodistribution, radiation dosimetry, and pharmacokinetics of SST001, an 18F-labeled PET tracer designed to detect α-Syn (alpha-synuclein) pathology. It will also measure whole-body radiation dose and brain uptake (SUVR) after tracer injection.

What the researchers hope to learn. To learn whether SST001 is safe and how it behaves in the body and brain, to estimate radiation dose, and to obtain brain uptake measurements that could inform future diagnostic research on α-Syn imaging.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • SST001

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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.

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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After consenting, participants receive an injection of the PET tracer SST001 and undergo PET imaging — including whole‑body scans and brain imaging at defined times after injection (study lists ~4 hours and ~80 minutes timepoints). Study staff will monitor safety (adverse-event checks, physical exams, vital signs, ECG, laboratory tests) with follow-up for the short safety window noted in the protocol. PET imaging and measurements will be used to study biodistribution and pharmacokinetics and to calculate radiation dosimetry.

How the study is structured. An interventional Phase I study that is open-label and non-randomized. All participants receive the investigational tracer SST001 (single-group). Procedures include administration of SST001, PET imaging, and safety monitoring with adverse-event assessment (primary safety window reported over 5 days). Secondary measures include whole-body dose (≈4 hours post-injection) and brain uptake (≈80 minutes post-injection).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on multiple system atrophy

Clinical trials76 trials listed for multiple system atrophyEvery trial the registry lists for multiple system atrophy, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in multiple system atrophy researchLatest monthly update: September 2026. Includes: Tube feeding. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jun 15, 2026
Primary completion
December 2026 (estimated)
Study completion
February 2027 (estimated)
Target enrollment
30 participants (estimated)
Last updated on registry
Sep 1, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Synusight Biotech (Shanghai) Co., Ltd.

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (2)

Terms used on this page · explanations by MedicalUpdates.ai

randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
pharmacokinetics
How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
inclusion criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
study drug
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
PET/CT
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
Prior therapy
Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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