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

August 15, 2018 updated by: MegaPro Biomedical Co. Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Find the max. signal change after IOP administration

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei county, Taiwan, 112
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IOP Injection, Phase 1b, Cohort 1
IV injection, 0.27 mg/kg
Drug: IOP Injection
T1 and T2
EXPERIMENTAL: IOP Injection, Phase 1b, Cohort 2
IV injection, 0.54 mg/kg
Drug: IOP Injection
T1 and T2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change of MRI SI (%) in vessels, liver, and spleen
Time Frame: Day1: within 60 mins after IOP administration
The optimal imaging time of IOP injection for the maximum SI (%)
Day1: within 60 mins after IOP administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes from baseline in hematology data
Time Frame: within 14 days
Complete blood count and differential count, Reticulocyte count
within 14 days
The incidence of all treatment-related adverse events (TRAE)
Time Frame: within 14 days
within 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MegaPro Biomedical Co. Ltd.

Investigators

  • Principal Investigator: Rheun-Chuan Lee, MD, rclee@vghtpe.gov.tw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2018

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

July 31, 2018

Study Registration Dates

First Submitted

January 2, 2018

First Submitted That Met QC Criteria

January 12, 2018

First Posted (ACTUAL)

January 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • IOP-CT-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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