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.