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

• Sponsor: Rockwell Medical Technologies, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01920854
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 15.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure, Chronic Therapy; Hemodialysis	Drug: soluble ferric pyrophosphate; Drug: Placebo	Phase 1

Detailed Description

• 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Intravenously Administered SFP in Healthy Volunteers
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Soluble Ferric Pyrophosphate Group/Cohort Designation: Ascending doses of SFP. Each subject will receive a defined dose of SFP IV administered under double-blind conditions. Pharmacokinetics of iron will be measured using a validated assay for iron and transferrin bound iron.	Drug: soluble ferric pyrophosphate; Other Names: SFP
Placebo Comparator: Control Group/Cohort Designation: Each subject will receive placebo IV administered under double-blind conditions.	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) [48 hours]

   Serum iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

2. Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected) [48 hours]

   Serum iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

3. Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected) [48 hours]

   Samples for transferrin-bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

4. Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected) [48 hours]

   Samples for transferrin-bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

5. Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute) [48 hours]

   Samples for total iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

6. Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute) [48 hours]

   Samples for total iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

7. Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected) [48 hours]

   Samples for non-transferrin bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

8. Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected) [48 hours]

   Samples for non-transferrin bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

9. Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected) [48 hours]

   Samples for unbound iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

10. Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected) [48 hours]

    Samples for unbound iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

11. Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6 [Baseline (1 day)]

    The mean baseline transferrin will be calculated based on samples drawn just prior to infusion for all Cohorts (both SFP and placebo)

Secondary Outcome Measures

1. Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated) [48 hours]

   Samples for transferrin saturation for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

2. Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated) [48 hours]

   Samples for transferrin saturation for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

3. Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last) [48 hours]

   Samples for three area under the curve (AUC) calculations (AUC 0-12, AUC 0 - 4, and AUC last) were collected for all Cohorts (both SFP and placebo). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

4. Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf) [48 hours]

   Samples for area under the curve from time-zero extrapolated to infinity (AUC inf) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

5. Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance]) [48 hours]

   Samples for Clearance (CL) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

6. Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max) [48 hours]

   Samples maximal baseline corrected concentration of iron (Cmax) calculations were collected for all Cohorts (both SFP and placebo). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

7. Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax) [48 hours]

   Samples for observed time to reach maximum iron concentration (Tmax) calculations were collected for all Cohorts (both SFP and placebo). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

8. Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose) [48 hours]

   Samples for the dose-normalized maximal baseline corrected concentration of iron (Cmax/dose) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

9. Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z) [48 hours]

   Samples for terminal phase rate constant (lambda z) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

10. Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2) [48 hours]

    Samples for terminal phase half life (t 1/2) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

11. Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz) [48 hours]

    Samples for volume of distribution in the terminal elimination phase (Vz) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Kalamazoo	Michigan	United States	49007

Sponsors and Collaborators

• Rockwell Medical Technologies, Inc.

Investigators

• Study Director: Raymond D Pratt, MD FACP, Rockwell Medical Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rockwell Medical Technologies, Inc.
• ClinicalTrials.gov Identifier: NCT01920854
• Other Study ID Numbers: RMTI-SFP-9
• First Posted: Aug 12, 2013
• Last Update Posted: Jan 26, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by Rockwell Medical Technologies, Inc.: Soluble Ferric Pyrophosphate, Pharmacokinetics, Iron, Hemodialysis
• Additional relevant MeSH terms: Renal Insufficiency; Kidney Failure, Chronic

Study Results

Participant Flow

Arm/Group Title	Cohorts 1 - 6 Placebo	Cohort 1 SFP	Cohort 2 SFP	Cohort 3 SFP	Cohort 4 SFP	Cohort 5 SFP	Cohort 6 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Period Title: Overall Study
STARTED	12	6	6	6	6	6	6
COMPLETED	11	6	6	6	5	6	5
NOT COMPLETED	1	0	0	0	1	0	1

Baseline Characteristics

Arm/Group Title	Cohorts 1 - 6 Placebo	Cohort 1 SFP	Cohort 2 SFP	Cohort 3 SFP	Cohort 4 SFP	Cohort 5 SFP	Cohort 6 SFP	Total
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.	Total of all reporting groups
Overall Participants	12	6	6	6	6	6	6	48
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	12 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	48 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	4 33.3%	2 33.3%	4 66.7%	3 50%	4 66.7%	5 83.3%	1 16.7%	23 47.9%
Male	8 66.7%	4 66.7%	2 33.3%	3 50%	2 33.3%	1 16.7%	5 83.3%	25 52.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%	1 16.7%	1 16.7%	0 0%	2 4.2%
Not Hispanic or Latino	12 100%	6 100%	6 100%	6 100%	5 83.3%	5 83.3%	6 100%	46 95.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	3 25%	1 16.7%	1 16.7%	0 0%	1 16.7%	1 16.7%	1 16.7%	8 16.7%
White	9 75%	5 83.3%	5 83.3%	6 100%	4 66.7%	5 83.3%	5 83.3%	39 81.3%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%	1 2.1%
Region of Enrollment (participants) [Number]
United States	12 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	48 100%

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
Description	Serum iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohorts 1 - 3, 6 Placebo	Cohort 1 SFP	Cohort 2 SFP	Cohort 3 SFP	Cohort 6 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Measure Participants	8	6	6	6	6
t = 0 hrs	18.87125 (19.08355)	14.625 (13.54503)	20.13333 (9.256061)	14.806 (10.09701)	31.73333 (17.07579)
t = 0.5 hrs	19.25243 (12.97435)	22.075 (15.44849)	33.21167 (16.22149)	41.53333 (17.55844)	58.65 (21.0115)
t = 1 hr	23.555 (16.79989)	40.34 (14.2365)	47.45 (19.26954)	67.24 (29.08003)	95.21667 (18.84658)
t = 2 hrs	32.54286 (32.58808)	73.15 (62.48)	88.28333 (22.29039)	119.34 (46.55242)	150.3333 (22.43806)
t = 3 hrs	41.3125 (31.5142)	77.64 (25.54981)	112.7333 (29.95721)	173.4 (17.38678)	210 (26.54807)
t = 4 hrs	43.75 (39.09914)	82.76 (10.01489)	143.4167 (33.93585)	206 (37.76242)	241.5 (25.6963)
t = 4.5 hrs	46.99 (33.692)	94.38 (12.827)	150.8 (39.0858)	196.25 (46.29885)	258.3333 (32.20973)
t = 5 hrs	50.74714 (39.71965)	88.88 (30.95007)	135.26 (40.90584)	207.5 (41.23469)	238.1667 (27.28675)
t = 6 hrs	46.3375 (32.43362)	86.1 (23.73584)	118.6 (40.09489)	179.0833 (40.56158)	214.5 (31.14322)
t = 7.5 hrs	26.27143 (25.89638)	49.33333 (35.15774)	81.35 (18.15717)	131.45 (31.91825)	170.8333 (27.63633)
t = 8 hrs	20.1875 (19.10194)	40.91667 (32.76452)	60.02833 (38.13224)	118.25 (38.3246)	148 (28.2772)
t = 9 hrs	7.852857 (25.84383)	30.75 (51.07636)	44.21667 (20.25452)	79.96 (32.5411)	122.6833 (21.64813)
t = 10 hrs	-0.1875 (18.48079)	-2.76 (32.67052)	24.02833 (19.2209)	64.68333 (37.53566)	81.01667 (25.26099)
t = 12 hrs	-11.8538 (20.68082)	-30.9866 (23.72293)	-5.89333 (17.29701)	23.21667 (42.48879)	32.91667 (22.9566)
t = 12.5 hrs	-11.7838 (24.1043)	-31.966 (22.61386)	-10.3888 (20.13357)	15.26667 (27.3353)	28.13333 (32.85319)
t = 14 hrs	-14.525 (23.13773)	-38.3883 (18.17201)	-22.5 (13.67333)	0.895 (27.98098)	-6.56617 (24.95741)
t = 16 hrs	-23.0004 (26.67792)	-39.5 (15.30849)	-19.905 (17.7931)	-12.35 (31.50294)	-23.5 (28.53482)
t = 20 hrs	-16.7163 (29.37565)	-43.8 (13.72461)	-23.655 (21.6553)	-11.0612 (15.55449)	-35.55 (22.41006)
t = 24 hrs	10.34714 (16.82299)	11.7 (33.80067)	6.542 (13.5174)	2.05 (15.61893)	-11.655 (20.10851)
t = 36 hrs	-4.24286 (15.34727)	-43.7666 (28.14838)	-9.72167 (20.08234)	-12.2612 (17.42613)	-27.3 (15.28005)
t = 48 hrs	21.73286 (19.95647)	11.47783 (44.51915)	21.82333 (19.21886)	41.4 (50.85712)	48.46 (18.48764)

2. Primary Outcome

Title	Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
Description	Serum iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohorts 4 and 5 Placebo	Cohort 4 SFP	Cohort 5 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
Measure Participants	4	6	6
t = 0 hrs	22.575 (8.144272)	15.55 (11.59451)	7.888333 (33.94121)
t = 0.5 hrs	21.7 (13.11602)	26.25 (13.70631)	29.97167 (33.57264)
t = 1 hr	23 (11.37629)	49.46667 (12.52576)	68.23333 (44.6479)
t = 2 hrs	24.9325 (17.2084)	77.62 (17.82826)	107.6333 (43.33413)
t = 4 hrs	41.16667 (32.85869)	140.2 (19.84187)	197.6667 (46.28031)
t = 6 hrs	42.975 (36.03807)	168.8 (35.75891)	232 (48.90808)
t = 9 hrs	17.6 (41.26835)	167.2 (42.3757)	228.8333 (44.96851)
t = 12 hrs	2.175 (29.20575)	176 (43.28972)	214.5 (49.31835)
t = 12.5 hrs	-5.53333 (28.14255)	141.3833 (49.73572)	208.1667 (51.0232)
t = 14 hrs	-2.9 (24.60732)	116.7 (47.4452)	161.9667 (46.50513)
t = 16 hrs	-19.1667 (15.64811)	38.18 (30.55899)	92.43833 (56.28477)
t = 18 hrs	-12.3 (13.66711)	25.84 (37.53582)	47.605 (37.80162)
t = 20 hrs	-5.2889 (7.137707)	-6.06667 (31.71553)	-3.09 (29.31886)
t = 24 hrs	21.62233 (19.48729)	-10.2333 (35.97225)	-20.0617 (26.62087)
t = 30 hrs	31.485 (48.38732)	-30.225 (27.25856)	-25.6333 (29.99492)
t = 36 hrs	-0.52333 (21.42192)	-23.15 (40.39885)	-34.6333 (41.33162)
t = 48 hrs	34.03333 (13.70632)	36.02 (26.44139)	19.95 (39.70616)

3. Primary Outcome

Title	Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
Description	Samples for transferrin-bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohorts 1 - 3, 6 Placebo	Cohort 1 SFP	Cohort 2 SFP	Cohort 3 SFP	Cohort 6 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Measure Participants	8	6	6	6	6
t = 0 hrs	15.81588 (15.29313)	27.45 (10.6442)	24.76667 (12.58438)	18.03333 (13.6192)	34.47833 (22.29513)
t = 0.5 hrs	16.12875 (16.956)	36.86667 (8.992145)	46.41667 (11.35067)	48.3 (16.06275)	62.93333 (20.16231)
t = 1 hr	24.04125 (23.55888)	51.73333 (10.18797)	70.8 (14.34489)	81.31667 (21.66614)	102.8 (22.60044)
t = 2 hrs	26.3875 (17.3591)	69.25 (11.37853)	112.55 (17.88449)	142.9 (27.52417)	166.6667 (22.00606)
t = 3 hrs	36.7375 (24.39203)	96.06667 (17.22355)	1148.3333 (26.3717)	194.3333 (39.70222)	223.6667 (21.58394)
t = 4 hrs	42.5375 (27.70637)	111.4167 (21.85437)	179.1667 (35.79618)	229.8333 (58.21483)	247.8333 (28.47045)
t = 4.5 hrs	46.3125 (26.86966)	113 (10.55936)	183.5 (37.35639)	230.5 (54.47844)	259.1667 (36.66833)
t = 5 hrs	47.8375 (31.67153)	105.95 (21.48299)	171.3333 (34.4248)	240.6667 (42.41541)	241.8333 (21.80291)
t = 6 hrs	39.7125 (23.02839)	95.5 (21.20547)	149 (31.89357)	188.95 (53.37429)	222.8333 (26.60388)
t = 7.5 hrs	21.84125 (16.90949)	62.58333 (27.26891)	95.25 (18.04658)	158.2667 (63.67312)	175.8333 (27.83822)
t = 8 hrs	16.7375 (14.66799)	50.58333 (27.42418)	84.1 (23.7459)	125.1 (50.25754)	154.1667 (30.0494)
t = 9 hrs	3.245 (9.291451)	30.23833 (30.05141)	52.21667 (17.32494)	104.1883 (51.15559)	125.35 (23.78098)
t = 10 hrs	-5.4175 (8.513109)	4.028333 (21.84233)	25.38333 (18.08142)	67.95 (42.27547)	87.16667 (31.49366)
t = 12 hrs	-18.8714 (17.95569)	-22.0445 (14.59163)	-7.33333 (19.53363)	28.65 (22.83486)	32.745 (29.99864)
t = 12.5 hrs	-22.8429 (22.18268)	-27.4617 (12.8595)	-10.2667 (22.21894)	15.68333 (19.74056)	24.82833 (38.29261)
t = 14 hrs	-25.4481 (27.93334)	-33.9617 (16.56204)	-14.85 (28.31902)	3.167167 (13.43837)	-6.195 (29.40307)
t = 16 hrs	-29.4667 (32.86135)	-35.8 (16.87637)	-23.4283 (26.12766)	-12.0333 (33.63212)	-28.2167 (30.50996)
t = 20 hrs	-20.7163 (31.3054)	-27.7 (30.14558)	-24.7233 (22.46531)	-18.1717 (16.19425)	-40.4883 (27.31494)
t = 24 hrs	14.05 (14.51925)	21.505 (37.16592)	0.116667 (16.23887)	7.605 (22.55452)	-16.455 (21.98194)
t = 36 hrs	-15.6767 (31.81849)	-39.8117 (31.90823)	-16.6567 (16.39093)	-11.74 (14.89775)	-37.3 (14.24949)
t = 48 hrs	25.4875 (16.85459)	26.68333 (51.62024)	35.36667 (12.16251)	40.945 (32.03071)	42.94 (12.77861)

4. Primary Outcome

Title	Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
Description	Samples for transferrin-bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohorts 4 and 5 Placebo	Cohort 4 SFP	Cohort 5 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
Measure Participants	4	6	6
t = 0 hrs	26.675 (10.10095)	17.13333 (13.10836)	22.31167 (25.13075)
t = 0.5 hrs	24.6 (12.80989)	32.36667 (14.44322)	46.76667 (25.7235)
t = 1 hr	31.35 (14.11772)	56.01667 (12.43309)	80.48333 (26.35234)
t = 2 hrs	35.75 (16.21532)	93.36667 (16.01058)	136.3333 (27.94041)
t = 4 hrs	50.9 (26.83927)	152 (14.02854)	222.5 (41.28801)
t = 6 hrs	55 (38.45179)	186.8 (27.12379)	255.5 (51.20059)
t = 9 hrs	24.285 (43.9688)	181.3333 (34.92659)	254.5 (60.24201)
t = 12 hrs	-0.975 (28.42761)	178.5 (47.26415)	236.8333 (62.58887)
t = 12.5 hrs	-3.86667 (28.73436)	157.6667 (47.00496)	237.8333 (68.42051)
t = 14 hrs	-7.03333 (19.74369)	117.3333 (45.18808)	180.65 (69.86598)
t = 16 hrs	-12.1867 (10.43401)	57.75 (41.30815)	114.3117 (73.84014)
t = 18 hrs	-11.52 (11.5913)	17.705 (33.84819)	58.51667 (63.66288)
t = 20 hrs	-0.67667 (20.99592)	-8.81667 (25.93025)	12.61167 (53.50657)
t = 24 hrs	30.39 (23.14673)	-12.0567 (25.6596)	-9.53833 (41.94388)
t = 30 hrs	26.44667 (41.6933)	-18.8283 (30.65685)	-22.9778 (23.78139)
t = 36 hrs	-5.4 (27.97803)	-28.1672 (32.82391)	-28.35 (35.19118)
t = 48 hrs	40.46667 (15.25036)	41.026 (34.08901)	30.78333 (48.96756)

5. Secondary Outcome

Title	Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
Description	Samples for transferrin saturation for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohorts 1 - 3, 6 Placebo	Cohort 1 SFP	Cohort 2 SFP	Cohort 3 SFP	Cohort 6 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Measure Participants	8	6	6	6	6
t = 0 hrs	25.70875 (18.521548)	41.85 (12.577559)	27.466667 (13.091626)	26.383333 (10.936986)	39.066667 (10.129495)
t = 0.5 hrs	26.375 (19.6707)	45.583333 (12.795533)	34.5 (12.94805)	35.716667 (11.168781)	47.85 (10.774368)
t = 1 hr	29.4125 (23.073141)	49.533333 (13.224019)	41.266667 (14.069921)	45.016667 (11.995902)	58.583333 (11.177373)
t = 2 hrs	29.5625 (21.098337)	56.15 (13.052624)	54.75 (15.895377)	63.05 (13.895719)	79.45 (14.417039)
t = 3 hrs	32.1875 (21.176904)	64.666667 (16.043898)	65.866667 (17.335128)	78.15 (14.831015)	96.066667 (12.873176)
t = 4 hrs	33.9625 (22.445867)	69.883333 (16.560002)	75.233333 (19.819048)	88.8 (11.348128)	102.83333 (7.5210815)
t = 4.5 hrs	34.1 (21.703917)	64.6 (12.73185)	74.25 (20.471614)	88.24 (13.994034)	102.93333 (10.715721)
t = 5 hrs	34.825 (24.362251)	66.8 (16.702934)	70.983333 (19.212227)	89.516667 (12.587679)	98.716667 (9.4961922)
t = 6 hrs	32.75 (21.835816)	64 (16.355427)	64.116667 (18.901896)	74.133333 (19.031938)	93.966667 (11.727688)
t = 7.5 hrs	29.375 (24.115659)	53.083333 (16.412973)	49.316667 (16.104089)	65.2 (18.721218)	80.483333 (13.813532)
t = 8 hrs	25.38625 (17.277825)	49.183333 (15.874182)	44.9 (17.190579)	56.15 (19.282298)	74.316667 (15.067902)
t = 9 hrs	23.18875 (18.870984)	41.866667 (14.993421)	35.533333 (15.038972)	50.483333 (18.139506)	65.816667 (13.489613)
t = 10 hrs	19.4325 (13.439108)	34.466667 (13.005794)	27.416667 (13.433453)	40.133333 (17.189842)	55.366667 (15.617127)
t = 12 hrs	16.518571 (9.4347451)	25.916667 (9.637306)	17.828333 (11.615611)	28.783333 (13.911925)	39.866667 (13.873812)
t = 12.5 hrs	15.968571 (9.7540546)	24.566667 (8.6832406)	16.771667 (11.701778)	25.618333 (12.537496)	36.866667 (14.673196)
t = 14 hrs	15.332857 (7.8527208)	22.483333 (8.5307483)	15.301667 (8.8581091)	21.486667 (10.91862)	28.716667 (13.00514)
t = 16 hrs	13.305714 (3.6857693)	23.366667 (10.372592)	12.835 (6.5323617)	15.85 (4.4440972)	22.2 (12.467879)
t = 20 hrs	14.835 (4.4686303)	25.916667 (10.491981)	12.386667 (4.4342606)	16.025 (7.9655351)	18.633333 (10.414157)
t = 24 hrs	24.4125 (10.022038)	40 (8.7824826)	19 (5.8845561)	22.733333 (8.7016474)	24.483333 (8.0759932)
t = 36 hrs	16.454286 (5.1594536)	19.883333 (5.2162886)	14.198333 (6.6138655)	17.441667 (9.7067696)	18.213333 (5.4371561)
t = 48 hrs	27.55 (15.727683)	40.533333 (14.972864)	29.383333 (11.362291)	31.766667 (17.181928)	41.58 (8.2156558)

6. Secondary Outcome

Title	Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
Description	Samples for transferrin saturation for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohorts 4 and 5 Placebo	Cohort 4 SFP	Cohort 5 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
Measure Participants	4	6	6
t = 0 hrs	30.95 (3.2583227)	26.5 (10.784062)	32.45 (10.532379)
t = 0.5 hrs	31.55 (4.2930176)	32.6 (11.667219)	41.3 (11.031591)
t = 1 hr	32.875 (4.7422744)	38.633333 (11.449658)	50.283333 (10.526997)
t = 2 hrs	34.525 (5.4267086)	50 (12.552928)	67.266667 (13.599069)
t = 4 hrs	38.95 (7.485319)	67.55 (12.12151)	92.833333 (14.211498)
t = 6 hrs	40.625 (11.092452)	73.56 (12.108179)	108.86667 (16.846325)
t = 9 hrs	31.925 (12.673956)	78.7 (16.428025)	107.55 (6.8625797)
t = 12 hrs	23.7 (7.7948701)	78.816667 (17.543935)	104.9 (10.529008)
t = 12.5 hrs	21.766667 (6.7337459)	71.483333 (20.245238)	100.31667 (12.198429)
t = 14 hrs	20.333333 (3.6855574)	57.733333 (15.467471)	82.15 (15.394902)
t = 16 hrs	18.833333 (0.5507571)	38.366667 (13.245628)	61.3 (17.549473)
t = 18 hrs	18.766667 (1.5821926)	26.5 (10.654201)	43.433333 (14.76383)
t = 20 hrs	22.133333 (5.0895317)	19.238333 (7.7310036)	29.966667 (11.375178)
t = 24 hrs	30.766667 (4.5763887)	17.683333 (4.5845029)	22.783333 (7.0024043)
t = 30 hrs	30.266667 (11.83737)	15.983333 (3.8012717)	18.45 (5.9949145)
t = 36 hrs	20.7 (7.2297994)	13.403333 (6.1446128)	17.383333 (8.9302669)
t = 48 hrs	33.133333 (3.1817186)	32.44 (17.400661)	34.633333 (12.038383)

7. Primary Outcome

Title	Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
Description	Samples for total iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohorts 1 - 3, 6 Placebo	Cohort 1 SFP	Cohort 2 SFP	Cohort 3 SFP	Cohort 6 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Measure Participants	8	6	6	6	6
t = 0 hrs	350 (44.2)	318 (28.3)	334 (23.8)	352 (53.1)	352 (35.9)
t = 0.5 hrs	344 (41.6)	312 (27.3)	328 (24.9)	344 (54.5)	348 (37.5)
t = 1 hr	345 (51.6)	318 (29.5)	334 (22.8)	348 (53.9)	352 (35.7)
t = 2 hrs	346 (45.6)	312 (31.9)	330 (29.9)	347 (56.6)	342 (36.6)
t = 3 hrs	348 (43)	313 (28.5)	329 (26.6)	344 (52.8)	342 (38.4)
t = 4 hrs	348 (41.1)	312 (29.4)	328 (23.4)	340 (51.2)	341 (37.4)
t = 4.5 hrs	359 (45.1)	324 (35.7)	339 (22.3)	337 (46.9)	352 (35.5)
t = 5 hrs	358 (43.6)	318 (27.6)	338 (24.4)	352 (42.6)	350 (37.9)
t = 6 hrs	356 (44)	315 (26)	338 (24.8)	356 (53.6)	348 (37.8)
t = 7.5 hrs	347 (56.1)	318 (27)	332 (29.3)	355 (52.8)	348 (36.1)
t = 8 hrs	359 (38.6)	319 (27.7)	339 (25.2)	356 (54.4)	348 (34.6)
t = 9 hrs	348 (51.6)	324 (27)	338 (29.6)	351 (47.2)	349 (34.9)
t = 10 hrs	352 (41.4)	317 (26.7)	338 (28.8)	355 (52.4)	347 (34.6)
t = 12 hrs	351 (43)	319 (26.3)	333 (29.5)	360 (53.5)	344 (33.5)
t = 12.5 hrs	344 (52.7)	316 (30.7)	336 (23.5)	351 (46.3)	350 (25.8)
t = 14 hrs	340 (61.9)	316 (31.1)	335 (31.8)	356 (48.4)	344 (39.6)
t = 16 hrs	341 (41.1)	304 (46.8)	327 (27.1)	353 (27.5)	344 (36.9)
t = 20 hrs	342 (48.8)	301 (40.8)	326 (23.4)	350 (52.3)	338 (32.4)
t = 24 hrs	355 (43.4)	314 (30.8)	346 (22.6)	362 (50)	353 (35)
t = 36 hrs	362 (39.4)	318 (24.8)	344 (24.6)	364 (50.4)	357 (38.4)
t = 48 hrs	364 (43.2)	320 (30.5)	346 (19.3)	370 (54.4)	352 (36.3)

8. Primary Outcome

Title	Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
Description	Samples for total iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohorts 4 and 5 Placebo	Cohort 4 SFP	Cohort 5 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
Measure Participants	4	6	6
t = 0 hrs	345 (22.3)	346 (49.8)	340 (41.1)
t = 0.5 hrs	332 (18.8)	328 (41.8)	328 (36.6)
t = 1 hr	340 (15.9)	338 (42)	336 (40.4)
t = 2 hrs	337 (17.6)	336 (43.8)	335 (36.6)
t = 4 hrs	338 (19.1)	336 (42.4)	335 (43.7)
t = 6 hrs	334 (22.9)	338 (40.8)	317 (41.3)
t = 9 hrs	330 (19.5)	324 (37.8)	318 (37.7)
t = 12 hrs	334 (33.3)	319 (40.2)	308 (35.1)
t = 12.5 hrs	333 (20.8)	325 (37.1)	323 (35.1)
t = 14 hrs	339 (19.3)	328 (41.7)	325 (31.8)
t = 16 hrs	338 (21.4)	340 (37.8)	325 (32.2)
t = 18 hrs	342 (13.9)	337 (40.2)	330 (34.3)
t = 20 hrs	337 (18.9)	329 (40.4)	325 (39)
t = 24 hrs	346 (31.2)	344 (43.3)	342 (39.4)
t = 30 hrs	344 (28.3)	339 (42.2)	350 (35.1)
t = 36 hrs	346 (33.7)	344 (46.4)	345 (35.4)
t = 48 hrs	352 (20.8)	337 (42.6)	343 (38.8)

9. Primary Outcome

Title	Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
Description	Samples for non-transferrin bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohorts 1 - 3, 6 Placebo	Cohort 1 SFP	Cohort 2 SFP	Cohort 3 SFP	Cohort 6 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Measure Participants	8	6	6	6	6
t = 0 hrs	2.98 (7.07)	-5.44 (5.35)	-4.66 (6.42)	-4.74 (7.01)	-1.42 (5.22)
t = 0.5 hrs	5.93 (11.5)	-7.54 (8.74)	-13.2 (9.7)	-7.65 (21.8)	-4.92 (6.33)
t = 1 hr	-0.554 (11.6)	-2.51 (10.1)	-23.4 (9)	-13.9 (35.8)	-7.54 (3.74)
t = 2 hrs	5.07 (19.6)	12 (53.5)	-24.5 (11.9)	-26.9 (29.5)	-13.8 (6.34)
t = 3 hrs	4.5 (15.9)	-11.9 (10.3)	-35.6 (9.85)	-23.7 (30.1)	-9.69 (6.81)
t = 4 hrs	1.17 (12.6)	-13.2 (19.8)	-35.7 (16.4)	-24.3 (23.5)	-6.96 (5.75)
t = 4.5 hrs	0.0952 (13.2)	-9.79 (26.5)	-32.9 (16.5)	-27 (22)	0.744 (13.3)
t = 5 hrs	1.01 (15.4)	-10.7 (11.5)	-32.7 (15)	-34 (19.7)	-2.92 (15.3)
t = 6 hrs	6.55 (20.1)	-10.1 (11.3)	-30.4 (13.4)	-11 (28)	-7.16 (13.5)
t = 7.5 hrs	3.3 (14.5)	-6.01 (10.1)	-13.9 (13.6)	-27.4 (44.4)	-5.09 (16.5)
t = 8 hrs	3.37 (10.6)	-2.43 (9.75)	-24 (20.1)	-7.72 (25.1)	-5.74 (11.1)
t = 9 hrs	6.31 (20.8)	7.69 (26.8)	-8.02 (7.3)	-27 (36)	-2.44 (16.2)
t = 10 hrs	5.16 (12.8)	1.51 (6.03)	-1.37 (4.46)	-4.22 (31.2)	-5.56 (11.3)
t = 12 hrs	9.52 (14.9)	-3.11 (9.14)	1.43 (5.26)	-6.32 (42.9)	-0.472 (16.2)
t = 12.5 hrs	12.7 (21.2)	1.17 (9.66)	-0.139 (6.84)	-1.3 (30.4)	2.66 (11.1)
t = 14 hrs	11 (12.8)	2.82 (12.6)	-3.44 (17.9)	-3.15 (28.3)	-1.01 (6.73)
t = 16 hrs	6.32 (11.1)	4.85 (12.7)	3.51 (10.3)	-1.2 (32.5)	4.08 (10.7)
t = 20 hrs	3.92 (9.3)	0.353 (22.2)	1.06 (6.27)	6.22 (25.3)	4.29 (6.91)
t = 24 hrs	-3.37 (4.87)	-6.39 (12.5)	5.47 (5.98)	-6.43 (31.1)	4.16 (9.23)
t = 36 hrs	2.97 (10)	1.51 (15.2)	6.93 (5.2)	-1.4 (23.6)	9.36 (8.63)
t = 48 hrs	-6.73 (14.6)	-7.56 (11.7)	-13.6 (19.7)	-1.65 (24.3)	4.74 (14.3)

10. Primary Outcome

Title	Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
Description	Samples for non-transferrin bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohorts 4 and 5 Placebo	Cohort 4 SFP	Cohort 5 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
Measure Participants	4	6	6
t = 0 hrs	-4.08 (2.22)	-1.58 (2.45)	-13.9 (25.8)
t = 0.5 hrs	-7.44 (8.71)	-5.95 (7.54)	-14.8 (26.7)
t = 1 hr	-6.63 (4.35)	-5.93 (8.93)	-9.99 (38.2)
t = 2 hrs	-10.4 (7.52)	-12.9 (23.4)	-20.7 (28.1)
t = 4 hrs	-6.57 (4.26)	-10.1 (8.65)	-17.6 (28.7)
t = 6 hrs	-10.8 (12.3)	-15.8 (16.4)	-18.1 (28.6)
t = 9 hrs	-6.53 (13.2)	-10.1 (18.3)	-19.8 (28.2)
t = 12 hrs	3.17 (2.29)	-11.7 (12.8)	-18.4 (22.4)
t = 12.5 hrs	-1.63 (1.54)	-16.3 (15.5)	-20.2 (28.3)
t = 14 hrs	0.0167 (1.39)	-3.38 (7.01)	-14.2 (33.5)
t = 16 hrs	-6.97 (13.6)	-6.93 (9.07)	-17.9 (29.5)
t = 18 hrs	-0.767 (9.7)	1.81 (8.29)	-8.14 (28)
t = 20 hrs	-4.6 (14.9)	2.75 (8.15)	-14.4 (31)
t = 24 hrs	-8.63 (8.31)	1.83 (16.3)	-10.8 (27.5)
t = 30 hrs	-3.68 (3.09)	1.22 (9.34)	-2.87 (35.6)
t = 36 hrs	4.9 (9.01)	5.32 (20.5)	-6.44 (29.2)
t = 48 hrs	-4.63 (1.7)	-4.03 (22.1)	-8.46 (36.1)

11. Primary Outcome

Title	Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
Description	Samples for unbound iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohorts 1 - 3, 6 Placebo	Cohort 1 SFP	Cohort 2 SFP	Cohort 3 SFP	Cohort 6 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Measure Participants	8	6	6	6	6
t = 0 hrs	-15.7 (16.3)	-27 (9.55)	-22.9 (10.7)	-17.9 (13.9)	-37.4 (24)
t = 0.5 hrs	-22.4 (19.4)	-41.5 (7.97)	-50.2 (10.7)	-56.8 (17.3)	-70.7 (23.8)
t = 1 hr	-29.1 (34.7)	-51.1 (9.91)	-68.7 (10.6)	-85.9 (19.2)	-106 (22.6)
t = 2 hrs	-30.3 (24.2)	-74.1 (10.9)	-115 (22.9)	-148 (25.9)	-179 (25.1)
t = 3 hrs	-38.9 (26.7)	-100 (21.4)	-152 (26.2)	-201 (39.2)	-229 (30.6)
t = 4 hrs	-44.8 (31.2)	-117 (22.6)	-182 (36.1)	-242 (58.8)	-246 (29.4)
t = 4.5 hrs	-37.9 (33.2)	-103 (10.6)	-175 (34.5)	-222 (59.4)	-243 (30.8)
t = 5 hrs	-39.9 (37.8)	-105 (25.5)	-166 (35.9)	-237 (60.6)	-239 (30.5)
t = 6 hrs	-34.5 (29.7)	-97.3 (25.8)	-143 (31.4)	-185 (50.9)	-228 (33.5)
t = 7.5 hrs	-25.1 (35.4)	-61.8 (28.7)	-95.3 (26.9)	-156 (68.9)	-183 (32.3)
t = 8 hrs	-8.54 (15.5)	-48.9 (26.6)	-77.4 (26.2)	-121 (52.5)	-161 (34.8)
t = 9 hrs	-5.54 (23.6)	-23.6 (22.9)	-46.5 (25.5)	-106 (56.4)	-132 (29.7)
t = 10 hrs	7 (12)	-3.71 (18.1)	-20 (23.6)	-65.7 (50.1)	-95.5 (34.9)
t = 12 hrs	19.4 (10.5)	24.4 (13.7)	8.56 (26.4)	-21.5 (33.7)	-43.7 (32)
t = 12.5 hrs	17.1 (10.6)	26 (13.6)	14 (32)	-16.7 (33.7)	-30.6 (34.4)
t = 14 hrs	16 (8.71)	32.8 (11.5)	17.7 (37.1)	0.667 (20)	-5.4 (34.1)
t = 16 hrs	21 (24.1)	22.5 (21.5)	18.5 (30.1)	10.8 (10.6)	16.5 (33.1)
t = 20 hrs	11.8 (19.4)	11.9 (28.5)	19 (25.4)	15.3 (15.5)	23.1 (26.3)
t = 24 hrs	-9.1 (13.8)	-24.7 (32.2)	13.8 (22.8)	1.57 (23)	14 (16.5)
t = 36 hrs	28.1 (28.6)	41.1 (30.1)	28.6 (19.5)	23.1 (15.1)	38.7 (21.1)
t = 48 hrs	-12.2 (25.3)	-23.4 (46.3)	-21.1 (16)	-23.8 (38.3)	-44.4 (18.4)

12. Primary Outcome

Title	Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
Description	Samples for unbound iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohorts 4 and 5 Placebo	Cohort 4 SFP	Cohort 5 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
Measure Participants	4	6	6
t = 0 hrs	-19.7 (8.82)	-12.4 (17.6)	-19.4 (29.5)
t = 0.5 hrs	-30.4 (11.6)	-46.5 (9.79)	-56.3 (29.7)
t = 1 hr	-29.7 (16.2)	-59.8 (8.85)	-81.3 (29.2)
t = 2 hrs	-37.1 (19.2)	-99.2 (14)	-138 (32.9)
t = 4 hrs	-51.2 (25.8)	-158 (21.6)	-216 (27.9)
t = 6 hrs	-58.7 (41.6)	-189 (38.5)	-247 (37.5)
t = 9 hrs	-32.4 (46.3)	-199 (41.6)	-246 (44.2)
t = 12 hrs	-3.59 (30.8)	-201 (51.9)	-241 (51.8)
t = 12.5 hrs	-1.21 (29.8)	-174 (66.1)	-236 (60.7)
t = 14 hrs	8.29 (17.2)	-131 (52.9)	-193 (76.1)
t = 16 hrs	11.8 (11.2)	-59.7 (58.2)	-126 (76.4)
t = 18 hrs	15.4 (20.3)	-22.3 (44.6)	-65.7 (65.6)
t = 20 hrs	-0.0778 (30.5)	-3.63 (33.6)	-24.7 (52.8)
t = 24 hrs	-22.8 (33.3)	14.6 (24.6)	14.3 (49.4)
t = 30 hrs	-20.9 (53.3)	15.9 (35.5)	35.8 (28.1)
t = 36 hrs	13.7 (39.4)	30.1 (37.7)	36.6 (34.6)
t = 48 hrs	-26.2 (25.3)	-35.8 (36.2)	-24.5 (54.8)

13. Secondary Outcome

Title	Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last)
Description	Samples for three area under the curve (AUC) calculations (AUC 0-12, AUC 0 - 4, and AUC last) were collected for all Cohorts (both SFP and placebo). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohorts 1 - 3, 6 Placebo	Cohorts 4, 5 Placebo	Cohort 1 SFP	Cohort 2 SFP	Cohort 3 SFP	Cohort 4 SFP	Cohort 5 SFP	Cohort 6 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 -3, 6 Placebo received IV D5W infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4, 5 Placebo received IV D5W infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Measure Participants	8	4	6	6	6	6	6	6
AUC 0 - 12	289 (235)	334 (412)	546 (312)	890 (258)	1420 (316)	1590 (336)	2210 (402)	1770 (222)
AUC 0 - 4	126 (103)	107 (68.8)	235 (104)	329 (84.8)	471 (97.7)	305 (56)	426 (151)	590 (76.7)
AUC last	340 (206)	277 (409)	579 (265)	903 (261)	1460 (340)	2070 (639)	3000 (677)	1820 (263)

14. Secondary Outcome

Title	Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf)
Description	Samples for area under the curve from time-zero extrapolated to infinity (AUC inf) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohort 1 SFP	Cohort 2 SFP	Cohort 3 SFP	Cohort 4 SFP	Cohort 5 SFP	Cohort 6 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Measure Participants	6	6	6	6	6	6
Mean (Standard Deviation) [h*microgram/dL]	675 (270)	1010 (190)	1650 (172)	2340 (565)	3150 (657)	1840 (263)

15. Secondary Outcome

Title	Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance])
Description	Samples for Clearance (CL) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohort 1 SFP	Cohort 2 SFP	Cohort 3 SFP	Cohort 4 SFP	Cohort 5 SFP	Cohort 6 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Measure Participants	6	6	6	6	6	6
Mean (Standard Deviation) [dL/hour]	4.06 (1.2)	5.11 (0.99)	4.59 (0.464)	6.72 (1.63)	6.61 (1.5)	5.56 (0.938)

16. Secondary Outcome

Title	Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max)
Description	Samples maximal baseline corrected concentration of iron (Cmax) calculations were collected for all Cohorts (both SFP and placebo). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohorts 1 - 3, 6 Placebo	Cohorts 4, 5 Placebo	Cohort 1 SFP	Cohort 2 SFP	Cohort 3 SFP	Cohort 4 SFP	Cohort 5 SFP	Cohort 6 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 -3, 6 Placebo received IV D5W infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4, 5 Placebo received IV D5W infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Measure Participants	8	4	6	6	6	6	6	6
Mean (Standard Deviation) [microgram/dL]	62.6 (32.4)	44.3 (34.8)	113 (44.5)	151 (33.9)	228 (19.7)	177 (38.2)	251 (51.7)	261 (30.3)

17. Secondary Outcome

Title	Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax)
Description	Samples for observed time to reach maximum iron concentration (Tmax) calculations were collected for all Cohorts (both SFP and placebo). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohorts 1 - 3, 6 Placebo	Cohorts 4, 5 Placebo	Cohort 1 SFP	Cohort 2 SFP	Cohort 3 SFP	Cohort 4 SFP	Cohort 5 SFP	Cohort 6 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 -3, 6 Placebo received IV D5W infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4, 5 Placebo received IV D5W infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Measure Participants	12	4	6	6	6	6	6	6
Median (Full Range) [hours]	4.5	6	4.5	4.5	4.75	7.5	6	4.5

18. Secondary Outcome

Title	Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose)
Description	Samples for the dose-normalized maximal baseline corrected concentration of iron (Cmax/dose) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohort 1 SFP	Cohort 2 SFP	Cohort 3 SFP	Cohort 4 SFP	Cohort 5 SFP	Cohort 6 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Measure Participants	6	6	6	6	6	6
Mean (Standard Deviation) [micrograms/dL/mg]	45.3 (17.8)	30.2 (6.78)	30.4 (2.63)	11.8 (2.55)	12.5 (2.59)	26.1 (3.03)

19. Secondary Outcome

Title	Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z)
Description	Samples for terminal phase rate constant (lambda z) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohort 1 SFP	Cohort 2 SFP	Cohort 3 SFP	Cohort 4 SFP	Cohort 5 SFP	Cohort 6 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Measure Participants	6	6	6	6	6	6
Mean (Standard Deviation) [1/hour]	0.544 (0.0788)	0.668 (0.281)	0.711 (0.423)	0.475 (0.262)	0.337 (0.114)	0.917 (0.688)

20. Secondary Outcome

Title	Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2)
Description	Samples for terminal phase half life (t 1/2) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohort 1 SFP	Cohort 2 SFP	Cohort 3 SFP	Cohort 4 SFP	Cohort 5 SFP	Cohort 6 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Measure Participants	6	6	6	6	6	6
Mean (Standard Deviation) [hours]	1.3 (0.187)	1.19 (0.476)	1.29 (0.721)	1.87 (1.08)	2.21 (0.549)	1.04 (0.505)

21. Secondary Outcome

Title	Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz)
Description	Samples for volume of distribution in the terminal elimination phase (Vz) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohort 1 SFP	Cohort 2 SFP	Cohort 3 SFP	Cohort 4 SFP	Cohort 5 SFP	Cohort 6 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Measure Participants	6	6	6	6	6	6
Mean (Standard Deviation) [dL]	7.65 (2.84)	8.43 (2.94)	8.59 (4.79)	16.6 (6.33)	20.8 (6.8)	8.33 (4.05)

22. Primary Outcome

Title	Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6
Description	The mean baseline transferrin will be calculated based on samples drawn just prior to infusion for all Cohorts (both SFP and placebo)
Time Frame	Baseline (1 day)

Outcome Measure Data

Analysis Population Description

The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Arm/Group Title	Cohorts 1 - 6 Placebo	Cohort 1 SFP	Cohort 2 SFP	Cohort 3 SFP	Cohort 4 SFP	Cohort 5 SFP	Cohort 6 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
Measure Participants	12	6	6	6	6	6	6
Mean (Standard Deviation) [mg/dL]	306.583 (35.1606)	283.500 (29.9850)	315.500 (40.7909)	348.333 (59.9956)	303.833 (47.2966)	314.571 (52.6841)	304.167 (53.2143)

Adverse Events

Arm/Group Title	Cohorts 1 - 6 Placebo		Cohort 1 SFP		Cohort 2 SFP		Cohort 3 SFP		Cohort 4 SFP		Cohort 5 SFP		Cohort 6 SFP
Arm/Group Description	A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).		A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.		A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.		A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.		A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.		A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.		A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
All Cause Mortality
	Cohorts 1 - 6 Placebo		Cohort 1 SFP		Cohort 2 SFP		Cohort 3 SFP		Cohort 4 SFP		Cohort 5 SFP		Cohort 6 SFP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Cohorts 1 - 6 Placebo		Cohort 1 SFP		Cohort 2 SFP		Cohort 3 SFP		Cohort 4 SFP		Cohort 5 SFP		Cohort 6 SFP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Cohorts 1 - 6 Placebo		Cohort 1 SFP		Cohort 2 SFP		Cohort 3 SFP		Cohort 4 SFP		Cohort 5 SFP		Cohort 6 SFP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/12 (25%)		0/6 (0%)		3/6 (50%)		2/6 (33.3%)		4/6 (66.7%)		0/6 (0%)		0/6 (0%)
Gastrointestinal disorders
nausea	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
abdominal discomfort	1/12 (8.3%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
diarrhoea	1/12 (8.3%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
General disorders
sensation of foreign body	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
infusion site pain	1/12 (8.3%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0
vessel puncture site hemorrhage	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0
infusion site swelling	1/12 (8.3%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Infections and infestations
nasopharyngitis	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0
Musculoskeletal and connective tissue disorders
back pain	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0
Nervous system disorders
headache	0/12 (0%)	0	0/6 (0%)	0	3/6 (50%)	3	1/6 (16.7%)	1	3/6 (50%)	3	0/6 (0%)	0	0/6 (0%)	0
dizziness	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	2/6 (33.3%)	2	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Reproductive system and breast disorders
dysmenorrhoea	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0
Skin and subcutaneous tissue disorders
hyperhidrosis	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Vascular disorders
flushing	0/12 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.