Magnetic Resonance Imaging
Conditions
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
Interventions
DRUGIOP Injection
T1 and T2
Sponsors
MegaPro Biomedical Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male, age ≥ 20 \ 40 years, BMI=18\ 27. 2. 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. 3. Male subjects must take reliable contraceptive method(s) during and after the study for a period of 14 days. 4. No screening of drug or alcohol abuse within one year prior to study enrollment. 5. Subjects are willing to comply with the protocol and sign informed consent form.
Exclusion criteria
1. Subjects have serious allergic history or known allergy to MRI contrast agent. 2. Subjects with HBV, HCV, HIV. 3. Imaging and/or functional abnormalities of liver and/or spleen. 4. Subjects have alcohol or caffeine consumption within 48 hours prior to the administration of study contrast agent. 5. Subjects have electronically, magnetically and mechanically activated implanted devices. 6. Subjects have participated in other investigational trials or receive any contrast agents within 28 days prior to study enrollment. 7. 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. 8. Subjects have taken any food 6 hours prior to administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change of MRI SI (%) in vessels, liver, and spleen | Day1: within 60 mins after IOP administration | The optimal imaging time of IOP injection for the maximum SI (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The changes from baseline in hematology data | within 14 days | Complete blood count and differential count, Reticulocyte count |
| The incidence of all treatment-related adverse events (TRAE) | within 14 days | — |
Countries
Taiwan
Outcome results
None listed