Clinical Trial: Safety and Pharmacokinetic Study of Escalating Multiple Doses of an Iron Chelator in Patients With Iron Overload

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

Official Title: A PHASE 1b OPEN LABEL, MULTI-CENTER, ESCALATING MULTIPLE DOSE STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF FBS0701 IN PATIENTS WITH TRANSFUSIONAL

  • Safety and tolerability by AEs, Physical Exam, Clinical Laboratory assessments [ Time Frame: 35 days (7 days treatment and 28 days follow up) ]
  • Steady state plasma level and half-life of FBS0701 [ Time Frame: 7 days of dosing ]


    • Original Primary Outcome: Same as current

    Current Secondary Outcome: Urinary excretion of iron [ Time Frame: 7 days of dosing ]

    Original Secondary Outcome: Same as current

    Information By: FerroKin BioSciences, Inc.

    Dates:
    Date Received: December 23, 2009
    Date Started: November 2009
    Date Completion:
    Last Updated: February 8, 2012
    Last Verified: January 2011