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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSynusight Biotech (Shanghai) Co., Ltd.

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Sign the informed consent form approved by IEC.

Male or female participants aged >18 years old.

Adequate organ functions.

Proper contraception methods.

Disqualifiers

Being pregnant or lactating.

History of other severe neurological disorders.

History of serious or uncontrolled medical condition.

Active HBV/HCV/HIV infection, etc.

Trial design

Design model

Single group

Treatments tested in this trial

  • SST001

    Drug

    Participants will undergo PET imaging after administration.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: SST001Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
5 days

Secondary outcomes

1

Whole Body Effective Dose

Whole body effective dose calculated from whole-body PET scans of healthy participants.

Time frame
Approximately 4 hours post injection
2

Standardized Uptake Value Ratio (SUVR)

SUVR of SST001 in brain regions of interest.

Time frame
Approximately 80 minutes post injection

Other outcomes

Sponsors and contacts

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