Clinical trial • Phase I • Other
NS12137 (radiolabelled with fluorine-18) for Healthy volunteers
Phase I trial of NS12137 (radiolabelled with fluorine-18) for Healthy volunteers. 15 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Healthy volunteers
- Trial Stage
- Phase I
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 04-10-2024
- First CTIS Authorization Date
- 04-02-2025
Trial design
Phase I trial across 1 site in Finland.
- Target Sample Size
- 15
Eligibility
Recruits 15 No vulnerable population selected (isVulnerablePopulationSelected: false). Participants are healthy volunteers; no consent/assent details provided in the record..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected: false). Participants are healthy volunteers; no consent/assent details provided in the record.
Recruitment
- Planned Sample Size
- 15
- Recruitment Window Months
- 12
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 15
Finland
- Earliest CTIS Part Ii Submission Date
- 16-12-2024
- Latest Decision Or Authorization Date
- 07-03-2025
- Processing Time Days
- 81
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- Varsinais-Suomen hyvinvointialue
- Department Name
- PET centre
- Principal Investigator Name
- Juha Rinne
- Principal Investigator Email
- juha.rinne@tyks.fi
- Contact Person Name
- Juha Rinne
- Contact Person Email
- juha.rinne@tyks.fi
- Number Of Participants
- 15
Sponsor
Primary sponsor
- Full Name
- Varsinais-Suomen hyvinvointialue
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Finland
Investigational products
- Investigational Product Name
- [18F]NS12137
- Active Substance
- NS12137 (radiolabelled with fluorine-18)
- Modality
- Radiopharmaceutical
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