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

Phase 1

Completed

• Conditions: Magnetic Resonance Imaging
• Interventions: Drug: IOP Injection

• Registration Number: NCT03399214
• Lead Sponsor: MegaPro Biomedical Co. Ltd.

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

Study Timeline

• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-12
• Study First Posted: 2018-01-16
• Study Start: 2018-04-01
• Primary Completion: 2018-05-01
• Study Completion: 2018-07-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
IOP Injection, Phase 1b, Cohort 1	IOP Injection	IV injection, 0.27 mg/kg
IOP Injection, Phase 1b, Cohort 2	IOP Injection	IV injection, 0.54 mg/kg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei county, Taiwan