Conditions: Kidney Failure, Chronic Therapy; Hemodialysis
Keywords: Soluble Ferric Pyrophosphate, Pharmacokinetics, Iron, Hemodialysis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 48
Healthy volunteers: yes

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

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.

Arms:
arm 1: 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. arm 2: Group/Cohort Designation: Each subject will receive placebo IV administered under double-blind conditions.

Interventions: intervention 1: soluble ferric pyrophosphate intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: