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

• ClinicalTrials.gov Identifier: NCT03485053
• Recruitment Status: Terminated
• First Posted: April 2, 2018
• Last Update Posted: October 28, 2021
• Sponsor: MegaPro Biomedical Co. Ltd.
• Information provided by (Responsible Party): MegaPro Biomedical Co. Ltd.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Iron Deficiency Anemia	Drug: IOP Injection / MPB-1514	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 49 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 2 Part, Phase II Study of Intravenous, Single Ascending Dose Administrations of IOP Injection in Patients With Iron Deficient Anemia
• Actual Study Start Date: November 29, 2018
• Actual Primary Completion Date: September 30, 2020
• Actual Study Completion Date: August 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. The mean difference in Hb from baseline [ Time Frame: on Day 28 ]
   Evaluate in IDA patients by assessing changes in hemoglobin (Hb) levels after dosing

Secondary Outcome Measures :

1. The number of subjects with treatment-related serious adverse events [ Time Frame: Day 0 to Day 28 ]
   Safety will be assessed using the incidence of treatment-related serious adverse events
2. Pharmacokinetic analysis of IOP Injection: Peak Plasma Concentration [ Time Frame: pre-dose to post-dose 24 hours ]
   Measurement of peak plasma concentration after dosing (Cmax)
3. Pharmacokinetic analysis of IOP Injection: Area Under the Plasma Concentration versus time [ Time Frame: pre-dose to post-dose 24 hours ]
   Measurement of area under the plasma concentration versus time curve (AUC)
4. Pharmacokinetic analysis of IOP Injection: Half-life in Plasma [ Time Frame: pre-dose to post-dose 24 hours ]
   Measurement of half-life of study drug in plasma after dosing (T1/2)

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, California

North America Research Institute

Azusa, California, United States, 91702

Valley Renal Medical Group

Northridge, California, United States, 91324

Whittier Internal Medicine and Nephrology Medical Group

Whittier, California, United States, 90602

United States, Florida

South Florida Research Institute

Lauderdale Lakes, Florida, United States, 33313

United States, New York

North Shore University Hospital Lab

Manhasset, New York, United States, 11030

Clinical Research Development Associates

Springfield Gardens, New York, United States, 11413

United States, Pennsylvania

Northeast Clinical Research Center

Bethlehem, Pennsylvania, United States, 18017

United States, Texas

Southwest Houston Research Ltd.

San Antonio, Texas, United States, 78227

Sponsors and Collaborators

MegaPro Biomedical Co. Ltd.

Investigators

• Principal Investigator: Steven Fishbane, MD; North Shore University Hospital

More Information

• Responsible Party: MegaPro Biomedical Co. Ltd.
• ClinicalTrials.gov Identifier: NCT03485053
• Other Study ID Numbers: IOP-CT-004
• First Posted: April 2, 2018
• Last Update Posted: October 28, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anemia; Anemia, Iron-Deficiency; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Metabolic Diseases