Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia

A Multi-Center, Randomized, Blinded, Placebo Controlled, Cross-Over Study to Investigate the Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia

The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia

Evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia

Inclusion Criteria:

• Subjects > or = 18 years of age and able to give informed consent
• Historical laboratory Hgb indicative of anemia within 3 months prior to screening visit
• Screening Visit laboratory Hgb indicative of anemia
• Screening Visit ferritin indicative of iron deficiency anemia

Exclusion Criteria:

• Known hypersensitivity to VIT-45
• Previously received VIT-45
• Parenteral iron in the 4 weeks prior to screening
• Chronic or serious active infection
• Malignancy history
• Aspartate aminotransferase (AST) or Alanine transaminase( ALT) greater than the upper limit of normal
• Anticipated need for surgery or initiation of dialysis during the study
• Pregnant or sexually active females who are not willing to use an effective form of birth control