A Single Ascending Dose Study of Soluble Ferric Pyrophosphate Administered Intravenously in Healthy Volunteers.

A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Intravenously Administered SFP in Healthy Volunteers

The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of intravenously administered Soluble Ferric Pyrophosphate

• A total of 48 healthy volunteers will be studied.
• Depending on the safety profile at completion of the highest dose cohort, an additional 2 cohorts of subjects may be studied.
• Doses of SFP may be modified, depending on the PK and safety findings at each dose level.
• Cohorts may be dropped for safety or tolerability after discussion with the sponsor.
• There will be 6 active and 2 placebo subjects in each study cohort.
• Subjects in Cohorts 1-3 will receive ascending doses of SFP by intravenous infusion over 4 hours.
• Subjects in Cohorts 4-6 will receive ascending doses of SFP by intravenous infusion over 12 hours.

All subjects will be confined in the CRC for 1 day prior to study drug administration and for 2 additional days for safety assessments and completion of test procedures.

Inclusion Criteria:

1. Age 18-55 inclusive at the time of consent. This inclusion criterion will only be assessed at the first screening visit.
2. Male or non-pregnant, non-lactating female who is at least 90 days post-partum.
3. Subject is willing to comply with any applicable contraceptive requirements of the protocol.
4. Satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination (PE), vital signs, electrocardiogram (ECG) and laboratory evaluation (hematology, biochemistry, urinalysis) as assessed by the Investigator.
5. An understanding, ability and willingness to fully comply with study procedures and restrictions.
6. Ability to provide written, personally signed and dated informed consent to participate in the study, in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures.
7. Body Mass Index (BMI) between 20.0 and 32.0 kg/m² inclusive. This inclusion criterion will only be assessed at the first screening visit.
8. Subjects must agree to discontinue all iron preparations for 14 days prior to study drug administration.

Exclusion Criteria:

1. Current or recurrent disease (e.g. cardiovascular, renal, liver, gastro-intestinal, malignancy or other conditions) that could affect the action, absorption or disposition of the investigational product utilized in this study, or could affect clinical or laboratory assessments.
2. Hemoglobin < 11 g/dL or Hematocrit < 30%.
3. Serum iron concentration ≤ 70 µg/dL (male or female).
4. Current or relevant previous history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or study procedures.
5. Significant illness, as judged by the investigator, within 2 weeks of the first dose of investigational product.
6. Current use of any medication (including prescription, over the counter [OTC], herbal or homeopathic preparations) within 14 days of first dose of investigational product. Exceptions are hormonal replacement therapy, hormonal contraceptives, acetaminophen and non-steroidal anti-inflammatory drugs.
7. Known or suspected intolerance or hypersensitivity to iron containing product(s).
8. History of alcohol or other substance abuse within the last year.
9. A positive screen for cotinine, alcohol or drugs of abuse.
10. Male subjects who consume more than 21 units of alcohol per week or three units per day. Female subjects who consume more than 14 units of alcohol per week or two units per day. 1 alcohol unit =1 beer = 1 wine (5oz) = 1 liquor (1.5 oz.).
11. A history of a positive human immunodeficiency virus (HIV) antibody screen, Hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV) antibody screen.
12. Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products in any form (e.g. gum, patch). Ex-users must report that they have stopped using tobacco for at least 30 days prior to receiving the first dose of investigational product.
13. Routine consumption of more than five units of caffeine per day or subjects who experience caffeine withdrawal headaches. One caffeine unit is contained in the following items: one 6-oz. cup of coffee, two 12-oz. cans of cola, one 12-oz. cup of tea, three 1-oz. chocolate bars.
14. Donation of blood or blood products (e.g., plasma or platelets) within 60 days prior to receiving the first dose of investigational product.
15. Use of another investigational product within 30 days prior to receiving the first dose of investigational product or active enrolment in another drug or vaccine clinical study.
16. Pregnancy or intention to become pregnant before completing all study drug treatment.
17. Current medical status that, in the investigators opinion, would preclude participation in the study.