A Single Ascending Study of IOP Injection in Patients With Iron Deficient Anemia

2 Part, Phase II Study of Intravenous, Single Ascending Dose Administrations of IOP Injection in Patients With Iron Deficient Anemia

The purpose is to evaluate the efficacy and safety of IOP Injection (MPB-1514) for the treatment of iron-deficient anemia (IDA).

Study Overview

• Status: Terminated
• Conditions: Iron Deficiency Anemia
• Intervention / Treatment: Drug: IOP Injection / MPB-1514

Detailed Description

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
• Enrollment (Actual): 49
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Azusa, California, United States, 91702
      • North America Research Institute
    • Northridge, California, United States, 91324
      • Valley Renal Medical Group
    • Whittier, California, United States, 90602
      • Whittier Internal Medicine and Nephrology Medical Group
  • Florida
    • Lauderdale Lakes, Florida, United States, 33313
      • South Florida Research Institute
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital Lab
    • Springfield Gardens, New York, United States, 11413
      • Clinical Research Development Associates
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Northeast Clinical Research Center
  • Texas
    • San Antonio, Texas, United States, 78227
      • SouthWest Houston Research LTD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject ≥ 18 years.
2. Subject with IDA but not secondary to any malignancy or renal failure requiring dialysis.
3. Hb levels <11.0 g/dL, Ferritin levels <200 ng/dL, Transferrin saturation (TSAT) < 20% at the Screening Visit.
4. Subject must have the ability to provide written, personally signed, and dated informed consent to participate in the study.
5. Subject must have an understanding, ability, and willingness to comply fully with study procedures and restrictions and to be available for clinic visits and follow-up procedures.
6. Female subject of child-bearing potential who is sexually active must use an effective method of birth control for at least one month prior to screening and agree to use an effective method of birth control until completion of participation in the study.

Exclusion Criteria:

1. Subject with known hemochromatosis, thalassemia, hemolytic anemia, receive red blood cell or whole blood transfusions within 90 days prior to enrollment.
2. Subject with a history of intravascular hemolysis.
3. Subject receiving any erythropoiesis-stimulating agent (ESA) therapy within 4 weeks prior to screenin.
4. Subject with a known sensitivity to any i.v. iron formulation
5. Subject with C-reactive protein > 20 mg/dL.
6. Subject with HBV, HCV, HIV.
7. Subject with known malignancy or severe renal failure requiring dialysis.
8. Subject with a recent (within 1 year of study drug administration) drug or alcohol abuse (including cannabis products) as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Diagnostic Criteria for Drug and Alcohol Abuse.
9. Subject averages an intake of more than 21 units of alcohol per week (≥ 3 drinks per day) for men and 14 units of alcohol per week (≥ 2 drinks per day) for women (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits).
10. Subject who has smoked or used smoking cessation or nicotine containing products (including but not limited to e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months of the first dose of study drug.
11. Subject with any factor, which in the opinion of the Investigator would jeopardize the evaluation or safety or be associated with poor adherence to the protocol.
12. Subject with psychiatric disorder precluding the understanding of information on study related topics or giving informed consent.
13. Subject who has received another investigational agent within 4 weeks prior to screening.
14. Subject undergoing major surgery or physical trauma within 90 days or with major burn injury covering > 20% of total body surface area.
15. Female subject who is pregnant or breast feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IOP Injection / MPB-1514; Administered IV infusion	Drug: IOP Injection / MPB-1514; Dilute with 5% Dextrose solution (D5W)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: MegaPro Biomedical Co. Ltd.
• Investigators: Principal Investigator: Steven Fishbane, MD, North Shore University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2018
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia
• Other Study ID Numbers: IOP-CT-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No