A Phase 2 interventional study of IOP Injection / MPB-1514 in Iron Deficiency Anemia, sponsored by MegaPro Biomedical Co. Ltd.. Terminated at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-28.
Sponsored by MegaPro Biomedical Co. Ltd. · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
Administered IV infusion
Drug: IOP Injection / MPB-1514
Dilute with 5% Dextrose solution (D5W)
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
Plan to share: No
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This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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MegaPro Biomedical Co. Ltd.