Phase Ib, Administration the IOP Injection for MRI Contrast Agent in Healthy Subjects

Magnetic Resonance Imaging Clinical Trial

Official title:

A Phase Ib Study to Evaluate Safety and Efficacy Profiles of IOP Injection for Magnetic Resonance Imaging (MRI) Contrast Agent in Healthy Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03399214
• Other study ID #: IOP-CT-002
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Magnetic Resonance Imaging

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