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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2018-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase I , MTD, Pharmacokinetic, Safety/Tolerability, Efficacy of IOP Injection for MRI in Healthy Subjects

NCT02744248

Magnetic Resonance Imaging

COMPLETED PHASE1

Contrast-enhanced Magnetic Resonance Imaging With Polysaccharide Superparamagnetic Iron Oxide Nanoparticle

NCT06010537

Magnetic Resonance Imaging

COMPLETED EARLY_PHASE1

Assessment of Investigational Magnetic Resonance Imaging and Post-Processing Procedures

NCT03490656

MRI Imaging

ACTIVE_NOT_RECRUITING NA

A Study of [13C]Pyruvate as an Imaging Agent for Magnetic Resonance Imaging in Healthy Volunteers

NCT05041166

Healthy Volunteers

ENROLLING_BY_INVITATION PHASE1

Assessing and Improving Quantitative Magnetic Resonance Imaging Metrics in Human Subjects

NCT05604534

Normal Physiology

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Find the max. signal change after IOP administration

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Magnetic Resonance Imaging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IOP Injection, Phase 1b, Cohort 1

IV injection, 0.27 mg/kg

Group Type EXPERIMENTAL

IOP Injection

Intervention Type DRUG

T1 and T2

IOP Injection, Phase 1b, Cohort 2

IV injection, 0.54 mg/kg

Group Type EXPERIMENTAL

IOP Injection

Intervention Type DRUG

T1 and T2

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IOP Injection

T1 and T2

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes