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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03399214
Other study ID # IOP-CT-002
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 1, 2018
Est. completion date July 31, 2018

Study information

Verified date August 2018
Source MegaPro Biomedical Co. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Find the max. signal change after IOP administration


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date July 31, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IOP Injection
T1 and T2

Locations

Country Name City State
Taiwan Taipei Veterans General Hospital Taipei county

Sponsors (1)

Lead Sponsor Collaborator
MegaPro Biomedical Co. Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Change of MRI SI (%) in vessels, liver, and spleen The optimal imaging time of IOP injection for the maximum SI (%) Day1: within 60 mins after IOP administration
Secondary The changes from baseline in hematology data Complete blood count and differential count, Reticulocyte count within 14 days
Secondary The incidence of all treatment-related adverse events (TRAE) within 14 days
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