Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers

Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for inclusion in the study:

• The subject must be able to provide informed consent and have personally signed and dated the study written informed consent document before completing any study-related procedures.
• The subject must be 18-65 years of age inclusive at the time of consent.
• The subject must have a transferrin saturation (TSAT) of 15-50% during Screening.
• The subject must agree to discontinue all iron preparations for 14 days prior to Baseline.
• If the subject is female, she must be premenopausal, non-pregnant and non-lactating, and be at least 90 days post-partum (if applicable) at Screening. Women of childbearing potential must be willing to use appropriate birth control during the entire duration of the study.
• The subject must be willing and able to comply with all study procedures and restrictions.
• The subject must have no clinically-significant abnormal findings on medical history, vital signs, physical examination, or clinical laboratory results during Screening.
• The subject must have a body mass index (BMI) of ≤32.0 kg/m2 at Screening and weigh >60.0 kg.

Exclusion Criteria

A subject will not be eligible for inclusion in the study if any of the following criteria apply:

• The subject has a hemoglobin (Hgb) concentration 5 mg/L during Screening, or any rheumatic or autoimmune disease that requires systemic anti-inflammatory or immunomodulatory therapy.
• Subject has an acute illness within 14 days prior to Baseline.
• Subject has known or suspected intolerance or hypersensitivity to iron-containing products.
• Subject has a history of alcohol or substance abuse within the past year.
• Subject has a positive screen for cotinine or drugs of abuse.
• Subject is positive for HIV, hepatitis B, or hepatitis C.
• Subject uses tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products in any form (e.g., gum, patch, etc.). Ex-users must report that they have stopped using tobacco for at least 30 days prior to Baseline.
• Subject donated blood or blood products (e.g., plasma or platelets) within 60 days prior to Baseline.
• Subject participated in an investigational drug study within 30 days prior to Baseline.
• Subject is pregnant or intends to become pregnant before completing the study.
• Subject's current medical status, in the investigator's opinion, would preclude participation in the study.