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

• Status: Completed
• Trial end date: 2017-06-04
• Target enrollment: 0
• Participant gender: All

Summary

The trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmacosmos A/S
• Treatments: Iron; Iron isomaltoside 1000

Criteria

Inclusion Criteria:

1. Japanese man or woman ≥ 20 years, < 65 years of age

2. Hb of ≥ 9.0 g/dL, < 12.0 g/dL for women and < 13.0 g/dL for men

3. Serum ferritin < 25 ng/mL

4. TIBC ≥ 360 μg/dL

5. Body weight ≥ 50 kg

6. Willingness to participate and signing the informed consent form

Exclusion criteria include:

1. Anemia caused by conditions other than iron deficiency

2. Cancer

3. IV or oral iron treatment, or blood transfusion 4 weeks prior to screening

4. Erythropoiesis stimulating agent (ESA) treatment prior to screening

5. Imminent expectation of blood transfusion on part of treating physician

6. Iron overload or disturbances (e.g. hemochromatosis and hemo-siderosis)

7. Known hypersensitivity reaction to iv iron preparations

8. Decompensated liver cirrhosis or active hepatitis

9. Active acute or chronic infections

10. Pregnant or nursing women.

11. Planned elective surgery during the trial