Unique ID issued by UMIN | UMIN000014286 |
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Receipt number | R000016477 |
Scientific Title | First-in-human study of I-123 IIMU. |
Date of disclosure of the study information | 2014/06/17 |
Last modified on | 2018/11/06 10:04:43 |
First-in-human study of I-123 IIMU.
First-in-human study of I-123 IIMU.
First-in-human study of I-123 IIMU.
First-in-human study of I-123 IIMU.
Japan |
Normal volunteers
Adult |
Others
NO
The objectives of this study were to evaluate radiation dosimetry,
biodistribution, human safety after injection of a single dose of the
tracer in healthy subjects.
Safety
Radiation Dosimetry, Whole-Organ Biodistribution and Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Medicine |
Period 8/2014 - 8/2015
20 | years-old | <= |
60 | years-old | > |
Male
Normal volunteers
(1) a history of hepatic or renal disease.
(2) a history of hypersensitivity for medical drugs.
(3) a history of drug abuse.
(4) a participation of other clinical trial within 6 months before
enrollment.
(5) any medical treatment including vitamin drug and Kanpo-drug within 14
days before enrollment.
(6) a donation of plasma to a blood bank or clinical study within 14 days
before enrollment.
a donation of over 200 ml whole blood to a blood bank or clinical study
within 28 days before enrollment.
a donation of over 400 ml whole blood to a blood bank or clinical study
within 84 days before enrollment.
a donation of over 800 ml whole blood to a blood bank or clinical study
within 365 days before enrollment.
(7) a history of iodine allergy.
(8)And subjects were excluded if the investigators judged as misfit for this study.
8
1st name | |
Middle name | |
Last name | Tohru Shiga |
Hokkaido University Hospital
Nuclear medicine
Kita15,Nishi7,Kita-ku,Sapporo
011-706-5152
tshiga@med.hokudai.ac.jp
1st name | |
Middle name | |
Last name | Tohru Shiga |
Hokkaido University Hospital
Nuclear medicine
Kita15,Nishi7,Kita-ku,Sapporo
011-706-5152
tshiga@med.hokudai.ac.jp
Hokkaido University Hospital
Hokkaido University Hospital
Nuclear medicine
Self funding
NO
2014 | Year | 06 | Month | 17 | Day |
Unpublished
Suspended
2014 | Year | 04 | Month | 01 | Day |
2015 | Year | 01 | Month | 15 | Day |
2014 | Year | 06 | Month | 17 | Day |
2018 | Year | 11 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016477
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