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

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03485053
• Other study ID #: IOP-CT-004
• Status: Terminated
• Phase: Phase 2
• Start date: November 29, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: October 2021
• Source: MegaPro Biomedical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: August 31, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency Anemia

Intervention

Drug:
• IOP Injection / MPB-1514
Dilute with 5% Dextrose solution (D5W)

Locations

Country	Name	City	State
United States	North America Research Institute	Azusa	California
United States	Northeast Clinical Research Center	Bethlehem	Pennsylvania
United States	South Florida Research Institute	Lauderdale Lakes	Florida
United States	North Shore University Hospital Lab	Manhasset	New York
United States	Valley Renal Medical Group	Northridge	California
United States	Southwest Houston Research Ltd.	San Antonio	Texas
United States	Clinical Research Development Associates	Springfield Gardens	New York
United States	Whittier Internal Medicine and Nephrology Medical Group	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
MegaPro Biomedical Co. Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean difference in Hb from baseline	Evaluate in IDA patients by assessing changes in hemoglobin (Hb) levels after dosing	on Day 28
Secondary	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
Secondary	Pharmacokinetic analysis of IOP Injection: Peak Plasma Concentration	Measurement of peak plasma concentration after dosing (Cmax)	pre-dose to post-dose 24 hours
Secondary	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
Secondary	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