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Clinical Trial 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.


Clinical Trial Description

Iron Oxide Nano Particle m-PEG-silane (IOP) Injection belongs to Superparamagnetic iron oxide (SPIO) can shorten the T2 relaxation time very effectively and reduces signal intensity in normal tissues. The mechanism of action increases after the particles have been phagocytosed by cells of the RES. Tissues with decreased RES function (e.g., metastases, primary liver cancer, cysts and various benign tumors, adenomas, and hyperplasia) retain their native signal intensity. In this study, investigators will characterize the PK profile, iron metabolism and preliminary efficacy of IOP Injection. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02744248
Study type Interventional
Source MegaPro Biomedical Co. Ltd.
Contact
Status Completed
Phase Phase 1
Start date February 2016
Completion date December 2017

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