Skip to content

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

First in human study on safety, pharmacokinetics and dose evaluation of brain histone deacetylase 6 imaging agent [18F]FSW-100 - First-in-Human study of [18F]FSW-100

Status
Recruiting
Phases
Phase 1
Study type
Unknown
Source
JPRN
Registry ID
JPRN-jRCTs031240173
Enrollment
11
Registered
2024-06-19
Start date
2024-06-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal subjects

Interventions

Positron emission tomography study using un-approved ligand [18F]FSW-100

Sponsors

Ishii Kenji
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

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

Secondary

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

Contacts

Public ContactMami Yoshioka

Tokyo Metropolitan Institute for Geriatrics and Gerontology

mami_yoshioka@haic.jp+81-3-3964-3241

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026