First-in-Human study of [18F]FSW-100

JRCT ID: jRCTs031240173

Registered date:19/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Normal subjects
• Date of first enrollment: 19/06/2024
• Target sample size: 11
• Study type: Other
• Intervention(s): Positron emission tomography study using un-approved ligand [18F]FSW-100

Outcome(s)

• Primary Outcome: Evaluation of safety, pharmacokinetics (metabolism, blood clearance, urinary excretion rate) and human radiation dosimetry associated with administration of [18F]FSW-100

Secondary Outcome

1.Optimization of data acquisition methods and scanning protocol
2.Establishment of quantification
3.Building appropriate methods for image evalua tion and analysis

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 60age old
• Gender: Male

Include criteria

The following criteria must be met by all subjects.
1. Males who are between 20 and 60 years old at the time of obtaining consent
2. Those who have given written consent to participate in this study

Exclude criteria

Subjects who have any of the following present or past history of illness:
1. Past history of neuropsychiatric illness such as epilepsy, major depression, or schizophrenia
2. Smokers
3. Subjects who are judged to be unsuitable for head MRI examination
4. Subjects with past history of severe drug hypersensitivity
5. Subjects with past history of cardiovascular disease
6. Subjects who are currently suffering from chronic anemia and chronic renal failure.
7. Subjects who are judged by the primary investigator to be ineligible for the study.

Related Information

• Primary Sponsor: Ishii Kenji