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

Study Overview
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Brief Summary
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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
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Find the max. signal change after IOP administration

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

Conditions
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Magnetic Resonance Imaging

Intervention / Treatment
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* Drug: IOP Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IOP Injection, Phase 1b, Cohort 1<br>IV injection, 0.27 mg/kg | Drug: IOP Injection<br>* T1 and T2<br>|
| Experimental: IOP Injection, Phase 1b, Cohort 2<br>IV injection, 0.54 mg/kg | Drug: IOP Injection<br>* T1 and T2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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