Safety evaluation of PET probe F18-NKO-035

JRCT ID: jRCTs051190057

Registered date:08/10/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Normal healthy volunteer
• Date of first enrollment: 14/11/2019
• Target sample size: 4
• Study type: Interventional
• Intervention(s): PET drug administration

Outcome(s)

• Primary Outcome: Estimation of whole body dose (effective dose) with F-18 NKO-035 administration (dose is similar to PET examination (4-8 mSv) using nuclide of same half life such as 18F-FDG-PET examination , Confirm that it does not exceed 10mSv.)

Secondary Outcome

Adverse events and side effects
Vital signs(systolic/diastolic blood pressure, pulse rate, respiratory rate, temperature)
Electrocardiography
Clinical examination( hematology, bold biochemistry, urinalysis)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Male

Include criteria

1) An adult male between 20 and 40 years of age
2) Person who is judged appropriate as a healthy person by a research principal doctor etc. after blood test, urine test and electrocardiogram test
3) Person who have obtained written consent for participation in this study from the applicant

Exclude criteria

1) Person with past medical history less than 1
Malignant tumor, endocrine disease, heart failure, severe respiratory disease, liver dysfunction, renal dysfunction
2) Persons who have a history of severe hypersensitivity to components of PET drugs used in this study
3) Persons who have undergone computed tomography (CT), PET or cardiac catheterization within the past year
4) Persons who were judged inappropriate by the investigator as a subject

Related Information

• Primary Sponsor: Watabe Tadashi
• Source(s) of Monetary Support: J-Pharma Co.,Ltd