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Sponsor terminate the trial and will conduct a phase 2b clinical trial further
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IOP Injection / MPB-1514 | Experimental | Administered IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IOP Injection / MPB-1514 | Drug | Dilute with 5% Dextrose solution (D5W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The mean difference in Hb from baseline | Evaluate in IDA patients by assessing changes in hemoglobin (Hb) levels after dosing | on Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects with treatment-related serious adverse events | Safety will be assessed using the incidence of treatment-related serious adverse events | Day 0 to Day 28 |
| Pharmacokinetic analysis of IOP Injection: Peak Plasma Concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Fishbane, MD | North Shore University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North America Research Institute | Azusa | California | 91702 | United States | ||
| Valley Renal Medical Group |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Measurement of peak plasma concentration after dosing (Cmax)
| 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) | 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) | pre-dose to post-dose 24 hours |
| Northridge |
| California |
| 91324 |
| United States |
| Whittier Internal Medicine and Nephrology Medical Group | Whittier | California | 90602 | United States |
| South Florida Research Institute | Lauderdale Lakes | Florida | 33313 | United States |
| North Shore University Hospital Lab | Manhasset | New York | 11030 | United States |
| Clinical Research Development Associates | Springfield Gardens | New York | 11413 | United States |
| Northeast Clinical Research Center | Bethlehem | Pennsylvania | 18017 | United States |
| Southwest Houston Research Ltd. | San Antonio | Texas | 78227 | United States |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |