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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
24
IOP Injection 20 mg Fe/ml, intravenous injection
0.9% normal saline 10 ml, intravenous injection
Taipei Veterans General Hospital
Taipei, Taiwan
Dose limiting toxicities (DLTs) of IOP
DLT is defined as any grade 2 or above toxicity by NCI-CTCAE version 4.03, as determined by the investigator and sponsor, to be at least possibly related in causality to the administered investigational product IOP
Time frame: Up to 14 days post-IOP injection
Maximum tolerated dose (MTD) of IOP
MTD is defined as the prior dose level below the dose level at which 2/6 subjects suffer dose limiting toxicities
Time frame: Up to 14 days post-IOP injection
Pharmacokinetic parameters-Cmax
Cmax: the observed maximum drug concentration in plasma after dosing
Time frame: Up to 3 days post-IOP injection
Pharmacokinetic parameters-Tmax
Tmax: the time at which Cmax was reached
Time frame: Up to 3 days post-IOP injection
Pharmacokinetic parameters-AUC0-t
the truncated area under the plasma concentration-time curve from the beginning of dosing to time t
Time frame: Up to 3 days post-IOP injection
Pharmacokinetic parameters-AUC0-inf
the area under the plasma concentration-time curve from the beginning of dosing to time t (AUC0-t) extrapolated to time infinity
Time frame: Up to 3 days post-IOP injection
Pharmacokinetic parameters-T1/2
terminal elimination half-life
Time frame: Up to 3 days post-IOP injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Changes in laboratory safety tests (hematology, biochemistry, urinalysis, bleeding time) from baseline
Time frame: Up to 14 days post-IOP injection