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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