Clinical trial NCT03485053: A Single Ascending Study of IOP Injection in Patients With Iron Deficient Anemia
Official title: 2 Part, Phase II Study of Intravenous, Single Ascending Dose Administrations of IOP Injection in Patients With Iron Deficient Anemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Iron Deficiency Anemia
Lead sponsor: MegaPro Biomedical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2018-04-02
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: The mean difference in Hb from baseline
timeFrame: on Day 28
Secondary outcomes:
measure: The number of subjects with treatment-related serious adverse events
timeFrame: Day 0 to Day 28
measure: Pharmacokinetic analysis of IOP Injection: Peak Plasma Concentration
timeFrame: pre-dose to post-dose 24 hours
measure: Pharmacokinetic analysis of IOP Injection: Area Under the Plasma Concentration versus time
timeFrame: pre-dose to post-dose 24 hours
measure: Pharmacokinetic analysis of IOP Injection: Half-life in Plasma
timeFrame: pre-dose to post-dose 24 hours
Other outcomes:
Locations:
city: Azusa
country: United States
facility: North America Research Institute
state: California
city: Northridge
country: United States
facility: Valley Renal Medical Group
state: California
city: Whittier
country: United States
facility: Whittier Internal Medicine and Nephrology Medical Group
state: California
city: Lauderdale Lakes
country: United States
facility: South Florida Research Institute
state: Florida
city: Manhasset
country: United States
facility: North Shore University Hospital Lab
state: New York
city: Springfield Gardens
country: United States
facility: Clinical Research Development Associates
state: New York
city: Bethlehem
country: United States
facility: Northeast Clinical Research Center
state: Pennsylvania
city: San Antonio
country: United States
facility: Southwest Houston Research Ltd.
state: Texas
Study officials:
affiliation: North Shore University Hospital
name: Steven Fishbane, MD
role: PRINCIPAL_INVESTIGATOR
References: