First-in-human study of I-123 IIMU.
- Conditions
- ormal volunteers
- Registration Number
- JPRN-UMIN000014286
- Lead Sponsor
- Hokkaido University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Male
- Target Recruitment
- 8
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Radiation Dosimetry, Whole-Organ Biodistribution and Safety
- Secondary Outcome Measures
Name Time Method