Status:
COMPLETED
Phase Ib, Administration the IOP Injection for MRI Contrast Agent in Healthy Subjects
Lead Sponsor:
MegaPro Biomedical Co. Ltd.
Conditions:
Magnetic Resonance Imaging
Eligibility:
MALE
20-40 years
Phase:
PHASE1
Brief Summary
The objective of the study is to assess the dose dependent changes in MRI signal intensity (SI) in liver after IOP Injection intravenous administration in healthy volunteers.
Detailed Description
Find the max. signal change after IOP administration
Eligibility Criteria
Inclusion
- Male, age ≥ 20 \~40 years, BMI=18\~27.
- The biochemistry test results, complete blood count (CBC) test results, urinalysis test results, coagulation time test results must within normal range or considered clinically normal by the clinical investigator at screening.
- Male subjects must take reliable contraceptive method(s) during and after the study for a period of 14 days.
- No screening of drug or alcohol abuse within one year prior to study enrollment.
- Subjects are willing to comply with the protocol and sign informed consent form.
Exclusion
- Subjects have serious allergic history or known allergy to MRI contrast agent.
- Subjects with HBV, HCV, HIV.
- Imaging and/or functional abnormalities of liver and/or spleen.
- Subjects have alcohol or caffeine consumption within 48 hours prior to the administration of study contrast agent.
- Subjects have electronically, magnetically and mechanically activated implanted devices.
- Subjects have participated in other investigational trials or receive any contrast agents within 28 days prior to study enrollment.
- Subjects with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action, adequate absorption and elimination of investigational contrast agent.
- Subjects have taken any food 6 hours prior to administration.
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03399214
Start Date
April 1 2018
End Date
July 31 2018
Last Update
August 17 2018
Active Locations (1)
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1
Taipei Veterans General Hospital
Taipei County, Taiwan, 112