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

NCT02744248 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-08-17

No results posted yet for this study

Summary

Study Objectives Primary: To determine MTD and dose limiting toxicities (DLTs) of IOP magnetic resonance imaging (MRI) contrast agent in healthy subjects.

Secondary:

1. To characterize the pharmacokinetic profiles of IOP MRI contrast agent in healthy subjects.
2. To evaluate safety/tolerability profiles of IOP MRI contrast agent in healthy subjects.
3. To explore efficacy profiles of IOP MRI contrast agent for liver organ in healthy subjects.

Conditions

  • Magnetic Resonance Imaging

Interventions

DRUG

IOP Injection

IOP Injection 20 mg Fe/ml, intravenous injection

DRUG

0.9% normal saline

0.9% normal saline 10 ml, intravenous injection

Sponsors & Collaborators

  • MegaPro Biomedical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Rheun-Chuan Lee · Taipei Veterans General Hospital, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-12-31
Completion
2017-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02744248 on ClinicalTrials.gov