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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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 Summary: 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.
Sponsor: MegaPro Biomedical Co. Ltd.

Current Primary Outcome:

  • Dose limiting toxicities (DLTs) of IOP [ Time Frame: Up to 14 days post-IOP injection ]
    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
  • Maximum tolerated dose (MTD) of IOP [ Time Frame: Up to 14 days post-IOP injection ]
    MTD is defined as the prior dose level below the dose level at which 2/6 subjects suffer dose limiting toxicities


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pharmacokinetic parameters-Cmax [ Time Frame: Up to 3 days post-IOP injection ]
    Cmax: the observed maximum drug concentration in plasma after dosing
  • Pharmacokinetic parameters-Tmax [ Time Frame: Up to 3 days post-IOP injection ]
    Tmax: the time at which Cmax was reached
  • Pharmacokinetic parameters-AUC0-t [ Time Frame: Up to 3 days post-IOP injection ]
    the truncated area under the plasma concentration-time curve from the beginning of dosing to time t
  • Pharmacokinetic parameters-AUC0-inf [ Time Frame: Up to 3 days post-IOP injection ]
    the area under the plasma concentration-time curve from the beginning of dosing to time t (AUC0-t) extrapolated to time infinity
  • Pharmacokinetic parameters-T1/2 [ Time Frame: Up to 3 days post-IOP injection ]
    terminal elimination half-life
  • Changes in laboratory safety tests (hematology, biochemistry, urinalysis, bleeding time) from baseline [ Time Frame: Up to 14 days post-IOP injection ]


Original Secondary Outcome:

  • Pharmacokinetic parameters-Cmax [ Time Frame: Up to 3 days post-IOP injection ]
    Cmax: the observed maximum drug concentration in plasma after dosing
  • Pharmacokinetic parameters-Tmax [ Time Frame: Up to 3 days post-IOP injection ]
    Tmax: the time at which Cmax was reached
  • Pharmacokinetic parameters-AUC0-t [ Time Frame: Up to 3 days post-IOP injection ]
    the truncated area under the plasma concentration-time curve from the beginning of dosing to time t
  • Pharmacokinetic parameters-AUC0-inf [ Time Frame: Up to 3 days post-IOP injection ]
    the area under the plasma concentration-time curve from the beginning of dosing to time t (AUC0-t) extrapolated to time infinity
  • Pharmacokinetic parameters-T1/2 [ Time Frame: Up to 3 days post-IOP injection ]
    terminal elimination half-life
  • The optimal imaging dose [ Time Frame: Up to 1 day post-IOP injection ]
  • Changes in laboratory safety tests (hematology, biochemistry, urinalysis, bleeding time) from baseline [ Time Frame: Up to 14 days post-IOP injection ]


Information By: MegaPro Biomedical Co. Ltd.

Dates:
Date Received: March 24, 2016
Date Started: February 2016
Date Completion:
Last Updated: January 9, 2017
Last Verified: January 2017