The purpose is to evaluate the efficacy and safety of IOP Injection (MPB-1514) for the treatment of iron-deficient anemia (IDA).
The Phase II study is to establish the maximum tolerated dose of i.v. IOP Injection (MPB-1514) in Part 1 and to evaluate the safety and efficacy of the maximally tolerated dose of IOP Injection with different infusions schemes in Part 2.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Dilute with 5% Dextrose solution (D5W)
North America Research Institute
Azusa, California, United States
Valley Renal Medical Group
Northridge, California, United States
Whittier Internal Medicine and Nephrology Medical Group
Whittier, California, United States
South Florida Research Institute
The mean difference in Hb from baseline
Evaluate in IDA patients by assessing changes in hemoglobin (Hb) levels after dosing
Time frame: on Day 28
The number of subjects with treatment-related serious adverse events
Safety will be assessed using the incidence of treatment-related serious adverse events
Time frame: Day 0 to Day 28
Pharmacokinetic analysis of IOP Injection: Peak Plasma Concentration
Measurement of peak plasma concentration after dosing (Cmax)
Time frame: pre-dose to post-dose 24 hours
Pharmacokinetic analysis of IOP Injection: Area Under the Plasma Concentration versus time
Measurement of area under the plasma concentration versus time curve (AUC)
Time frame: pre-dose to post-dose 24 hours
Pharmacokinetic analysis of IOP Injection: Half-life in Plasma
Measurement of half-life of study drug in plasma after dosing (T1/2)
Time frame: pre-dose to post-dose 24 hours
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Lauderdale Lakes, Florida, United States
North Shore University Hospital Lab
Manhasset, New York, United States
Clinical Research Development Associates
Springfield Gardens, New York, United States
Northeast Clinical Research Center
Bethlehem, Pennsylvania, United States
Southwest Houston Research Ltd.
San Antonio, Texas, United States