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

NCT03485053 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: IOP-CT-004
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• The mean difference in Hb from baseline

  Evaluate in IDA patients by assessing changes in hemoglobin (Hb) levels after dosing

  on Day 28

Secondary Outcomes (4)

• The number of subjects with treatment-related serious adverse events

  Day 0 to Day 28

• Pharmacokinetic analysis of IOP Injection: Peak Plasma Concentration

  pre-dose to post-dose 24 hours

• Pharmacokinetic analysis of IOP Injection: Area Under the Plasma Concentration versus time

  pre-dose to post-dose 24 hours

• Pharmacokinetic analysis of IOP Injection: Half-life in Plasma

  pre-dose to post-dose 24 hours

Study Arms (1)

IOP Injection / MPB-1514

EXPERIMENTAL

Administered IV infusion

Drug: IOP Injection / MPB-1514

Interventions

IOP Injection / MPB-1514 DRUG

Dilute with 5% Dextrose solution (D5W)

IOP Injection / MPB-1514

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject ≥ 18 years.
• Subject with IDA but not secondary to any malignancy or renal failure requiring dialysis.
• Hb levels \<11.0 g/dL, Ferritin levels \<200 ng/dL, Transferrin saturation (TSAT) \< 20% at the Screening Visit.
• Subject must have the ability to provide written, personally signed, and dated informed consent to participate in the study.
• 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.
• 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.

You may not qualify if:

• Subject with known hemochromatosis, thalassemia, hemolytic anemia, receive red blood cell or whole blood transfusions within 90 days prior to enrollment.
• Subject with a history of intravascular hemolysis.
• Subject receiving any erythropoiesis-stimulating agent (ESA) therapy within 4 weeks prior to screenin.
• Subject with a known sensitivity to any i.v. iron formulation
• Subject with C-reactive protein \> 20 mg/dL.
• Subject with HBV, HCV, HIV.
• Subject with known malignancy or severe renal failure requiring dialysis.
• 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.
• 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).
• 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.
• 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.
• Subject with psychiatric disorder precluding the understanding of information on study related topics or giving informed consent.
• Subject who has received another investigational agent within 4 weeks prior to screening.
• Subject undergoing major surgery or physical trauma within 90 days or with major burn injury covering \> 20% of total body surface area.
• Female subject who is pregnant or breast feeding.

Sponsors & Collaborators

• MegaPro Biomedical Co. Ltd.: lead

Study Sites (8)

North America Research Institute

Azusa, California, 91702, United States

Location

Valley Renal Medical Group

Northridge, California, 91324, United States

Location

Whittier Internal Medicine and Nephrology Medical Group

Whittier, California, 90602, United States

Location

South Florida Research Institute

Lauderdale Lakes, Florida, 33313, United States

Location

North Shore University Hospital Lab

Manhasset, New York, 11030, United States

Location

Clinical Research Development Associates

Springfield Gardens, New York, 11413, United States

Location

Northeast Clinical Research Center

Bethlehem, Pennsylvania, 18017, United States

Location

Southwest Houston Research Ltd.

San Antonio, Texas, 78227, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Steven Fishbane, MD

  North Shore University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 2, 2018
• Study Start: November 29, 2018
• Primary Completion: September 30, 2020
• Study Completion: August 31, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)