Normal healthy volunteer VLA-4 PET diagnosis
Conditions
Interventions
Sponsors
Watabe Tadashi
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) An adult male between 18 and 45 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
Exclusion criteria
Exclusion criteria: 1) Person with past medical history 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 PET or cardiac catheterization within the past year 4) Persons who were judged inappropriate as a subject by the investigator and the co-research physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimation of whole body dose (effective dose) with C11-HCA2969 administration (Confirm that the effective dose does not exceed 10mSv, which is the upper limit of dose constraints under international standards. For reference, the threshold values for each organ specified by the US Radioactive Drug Research Committee regulation do not exceed 30 mSv (whole body, hematopoietic organs, lens of the eye, gonads) and 50 mSv (others).) Adverse events and side effects | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs(systolic/diastolic blood pressure, pulse rate, respiratory rate, temperature) Electrocardiography Clinical examination (hematology, bold biochemistry, urinalysis) Pharmacokinetic evaluation (chronological changes in accumulation in major organs, changes in blood concentration, urinary excretion dynamics) | — |
Contacts
Public ContactTadashi Watabe
The University of Osaka Hospital
Outcome results
None listed