Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®)

IDA is highly prevalent in subjects with cancer and gastrointestinal diseases such as inflammatory bowel diseases, menstruating or pregnant women, and subjects who have undergone bariatric procedure. IDA can have a substantial medical and quality of life (QoL) burden on the subjects, and treatment of these subjects includes controlling the bleeding and replenishing lost iron.

Inclusion criteria

• Japanese man or woman ≥ 20 years, < 65 years of age
• Hb of ≥ 9.0 g/dL, < 12.0 g/dL for women and < 13.0 g/dL for men
• Serum ferritin < 25 ng/mL
• TIBC ≥ 360 μg/dL
• Body weight ≥ 50 kg
• Willingness to participate and signing the informed consent form

Exclusion criteria

include:

• Anemia caused by conditions other than iron deficiency
• Cancer
• IV or oral iron treatment, or blood transfusion 4 weeks prior to screening
• Erythropoiesis stimulating agent (ESA) treatment prior to screening
• Imminent expectation of blood transfusion on part of treating physician
• Iron overload or disturbances (e.g. hemochromatosis and hemo-siderosis)
• Known hypersensitivity reaction to iv iron preparations
• Decompensated liver cirrhosis or active hepatitis
• Active acute or chronic infections
• Pregnant or nursing women.
• Planned elective surgery during the trial