A Phase 1 interventional study of soluble ferric pyrophosphate and Placebo in Kidney Failure, Chronic Therapy; Hemodialysis, sponsored by Rockwell Medical Technologies, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-26.
Sponsored by Rockwell Medical Technologies, Inc. · Phase 1, Interventional, and Treatment
The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of intravenously administered Soluble Ferric Pyrophosphate
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.
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Exclusion Criteria:
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
Group/Cohort Designation: Each subject will receive placebo IV administered under double-blind conditions.
Drug: Placebo
Also known as: SFP
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
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
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
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
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
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
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
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
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
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
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
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
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
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
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
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
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
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
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
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
Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6
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)
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
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
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
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
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)
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
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf)
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
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance])
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
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max)
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
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax)
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
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose)
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
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z)
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
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2)
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
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz)
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
| Milestone | Cohorts 1 - 6 Placebo | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 4 SFP | Cohort 5 SFP | Cohort 6 SFP |
|---|---|---|---|---|---|---|---|
| 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 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 | 1 | 0 | 1 |
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.
| micrograms/dL | Cohorts 1 - 3, 6 Placebo | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 6 SFP |
|---|---|---|---|---|---|
| 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 |
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.
| micrograms/dL | Cohorts 4 and 5 Placebo | Cohort 4 SFP | Cohort 5 SFP |
|---|---|---|---|
| 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 |
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.
| micrograms/dL | Cohorts 1 - 3, 6 Placebo | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 6 SFP |
|---|---|---|---|---|---|
| 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 |
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.
| micrograms/dL | Cohorts 4 and 5 Placebo | Cohort 4 SFP | Cohort 5 SFP |
|---|---|---|---|
| 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 |
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.
| percentage of saturation | Cohorts 1 - 3, 6 Placebo | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 6 SFP |
|---|---|---|---|---|---|
| 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 |
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.
| percentage of saturation | Cohorts 4 and 5 Placebo | Cohort 4 SFP | Cohort 5 SFP |
|---|---|---|---|
| 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 |
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.
| micrograms/dL | Cohorts 1 - 3, 6 Placebo | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 6 SFP |
|---|---|---|---|---|---|
| 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 |
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.
| micrograms/dL | Cohorts 4 and 5 Placebo | Cohort 4 SFP | Cohort 5 SFP |
|---|---|---|---|
| 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 |
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.
| micrograms/dL | Cohorts 1 - 3, 6 Placebo | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 6 SFP |
|---|---|---|---|---|---|
| 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 |
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.
| micrograms/dL | Cohorts 4 and 5 Placebo | Cohort 4 SFP | Cohort 5 SFP |
|---|---|---|---|
| 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 |
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.
| micrograms/dL | Cohorts 1 - 3, 6 Placebo | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 6 SFP |
|---|---|---|---|---|---|
| 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 |
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.
| micrograms/dL | Cohorts 4 and 5 Placebo | Cohort 4 SFP | Cohort 5 SFP |
|---|---|---|---|
| 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 |
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.
| h*microgram/dL | 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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
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.
| h*microgram/dL | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 4 SFP | Cohort 5 SFP | Cohort 6 SFP |
|---|---|---|---|---|---|---|
| Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf) | 675 ± 270 | 1010 ± 190 | 1650 ± 172 | 2340 ± 565 | 3150 ± 657 | 1840 ± 263 |
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.
| dL/hour | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 4 SFP | Cohort 5 SFP | Cohort 6 SFP |
|---|---|---|---|---|---|---|
| Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance]) | 4.06 ± 1.2 | 5.11 ± 0.99 | 4.59 ± 0.464 | 6.72 ± 1.63 | 6.61 ± 1.5 | 5.56 ± 0.938 |
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.
| microgram/dL | 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 |
|---|---|---|---|---|---|---|---|---|
| Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max) | 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 |
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.
| hours | 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 |
|---|---|---|---|---|---|---|---|---|
| Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax) | 4.5 (0.5 to 6) | 6 (4 to 6) | 4.5 (2 to 9) | 4.5 (4 to 4.5) | 4.75 (4 to 6) | 7.5 (6 to 12) | 6 (4 to 12.1) | 4.5 (4 to 4.5) |
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.
| micrograms/dL/mg | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 4 SFP | Cohort 5 SFP | Cohort 6 SFP |
|---|---|---|---|---|---|---|
| Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose) | 45.3 ± 17.8 | 30.2 ± 6.78 | 30.4 ± 2.63 | 11.8 ± 2.55 | 12.5 ± 2.59 | 26.1 ± 3.03 |
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.
| 1/hour | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 4 SFP | Cohort 5 SFP | Cohort 6 SFP |
|---|---|---|---|---|---|---|
| Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z) | 0.544 ± 0.0788 | 0.668 ± 0.281 | 0.711 ± 0.423 | 0.475 ± 0.262 | 0.337 ± 0.114 | 0.917 ± 0.688 |
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.
| hours | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 4 SFP | Cohort 5 SFP | Cohort 6 SFP |
|---|---|---|---|---|---|---|
| Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2) | 1.3 ± 0.187 | 1.19 ± 0.476 | 1.29 ± 0.721 | 1.87 ± 1.08 | 2.21 ± 0.549 | 1.04 ± 0.505 |
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.
| dL | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 4 SFP | Cohort 5 SFP | Cohort 6 SFP |
|---|---|---|---|---|---|---|
| Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz) | 7.65 ± 2.84 | 8.43 ± 2.94 | 8.59 ± 4.79 | 16.6 ± 6.33 | 20.8 ± 6.8 | 8.33 ± 4.05 |
The mean baseline transferrin will be calculated based on samples drawn just prior to infusion for all Cohorts (both SFP and placebo)
| mg/dL | Cohorts 1 - 6 Placebo | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 4 SFP | Cohort 5 SFP | Cohort 6 SFP |
|---|---|---|---|---|---|---|---|
| Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6 | 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 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohorts 1 - 6 Placebo | — | 0/12 (0%) | 3/12 (25%) |
| Cohort 1 SFP | — | 0/6 (0%) | 0/6 (0%) |
| Cohort 2 SFP | — | 0/6 (0%) | 3/6 (50%) |
| Cohort 3 SFP | — | 0/6 (0%) | 2/6 (33.3%) |
| Cohort 4 SFP | — | 0/6 (0%) | 4/6 (66.7%) |
| Cohort 5 SFP | — | 0/6 (0%) | 0/6 (0%) |
| Cohort 6 SFP | — | 0/6 (0%) | 0/6 (0%) |
| Event | Cohorts 1 - 6 Placebo | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 4 SFP | Cohort 5 SFP | Cohort 6 SFP |
|---|---|---|---|---|---|---|---|
| headacheNervous system disorders | 0/12 | 0/6 | 3/6 | 1/6 | 3/6 | 0/6 | 0/6 |
| dizzinessNervous system disorders | 0/12 | 0/6 | 0/6 | 2/6 | 0/6 | 0/6 | 0/6 |
| flushingVascular disorders | 0/12 | 0/6 | 1/6 | 0/6 | 0/6 | 0/6 | 0/6 |
| sensation of foreign bodyGeneral disorders | 0/12 | 0/6 | 0/6 | 1/6 | 0/6 | 0/6 | 0/6 |
| nauseaGastrointestinal disorders | 0/12 | 0/6 | 0/6 | 1/6 | 0/6 | 0/6 | 0/6 |
| hyperhidrosisSkin and subcutaneous tissue disorders | 0/12 | 0/6 | 0/6 | 1/6 | 0/6 | 0/6 | 0/6 |
| infusion site painGeneral disorders | 1/12 | 0/6 | 0/6 | 0/6 | 1/6 | 0/6 | 0/6 |
| vessel puncture site hemorrhageGeneral disorders | 0/12 | 0/6 | 0/6 | 0/6 | 1/6 | 0/6 | 0/6 |
| nasopharyngitisInfections and infestations | 0/12 | 0/6 | 0/6 | 0/6 | 1/6 | 0/6 | 0/6 |
| dysmenorrhoeaReproductive system and breast disorders | 0/12 | 0/6 | 0/6 | 0/6 | 1/6 | 0/6 | 0/6 |
| Age, Categorical(Participants) | Cohorts 1 - 6 Placebo | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 4 SFP | Cohort 5 SFP | Cohort 6 SFP | Total |
|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 6 | 6 | 6 | 6 | 6 | 6 | 48 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Cohorts 1 - 6 Placebo | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 4 SFP | Cohort 5 SFP | Cohort 6 SFP | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 4 | 2 | 4 | 3 | 4 | 5 | 1 | 23 |
| Male | 8 | 4 | 2 | 3 | 2 | 1 | 5 | 25 |
| Ethnicity (NIH/OMB)(Participants) | Cohorts 1 - 6 Placebo | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 4 SFP | Cohort 5 SFP | Cohort 6 SFP | Total |
|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 2 |
| Not Hispanic or Latino | 12 | 6 | 6 | 6 | 5 | 5 | 6 | 46 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohorts 1 - 6 Placebo | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 4 SFP | Cohort 5 SFP | Cohort 6 SFP | Total |
|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 1 | 0 | 1 | 1 | 1 | 8 |
| White | 9 | 5 | 5 | 6 | 4 | 5 | 5 | 39 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Region of Enrollment(participants) | Cohorts 1 - 6 Placebo | Cohort 1 SFP | Cohort 2 SFP | Cohort 3 SFP | Cohort 4 SFP | Cohort 5 SFP | Cohort 6 SFP | Total |
|---|---|---|---|---|---|---|---|---|
| United States | 12 | 6 | 6 | 6 | 6 | 6 | 6 | 48 |
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Rockwell Medical Technologies, Inc.