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

MegaPro Biomedical

Status and phase: Completed; Phase 1

Conditions: Magnetic Resonance Imaging

Treatments: Drug: IOP Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03399214

IOP-CT-002

Details and patient eligibility

About

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.

Full description

Find the max. signal change after IOP administration

Enrollment: 12 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

IOP Injection, Phase 1b, Cohort 1

Experimental group

Description:

IV injection, 0.27 mg/kg

Treatment:

Drug: IOP Injection

IOP Injection, Phase 1b, Cohort 2

Experimental group

Description:

IV injection, 0.54 mg/kg

Treatment:

Drug: IOP Injection