NCT02744248

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

A Phase I Study to Determine the MTD and to Evaluate Pharmacokinetic, Safety/Tolerability, and Efficacy Profiles of IOP Injection for MRI Contrast Agent in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: MegaPro Biomedical Co. Ltd. · Industry
• Sex: Male
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Magnetic Resonance Imaging

Interventions

Type	Name	Description
DRUG	IOP Injection	IOP Injection 20 mg Fe/ml, intravenous injection
DRUG	0.9% normal saline	0.9% normal saline 10 ml, intravenous injection

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2016-04-20
• Last updated: 2018-08-17

Locations

1 site across 1 country: Taiwan