Kidney Failure, Chronic Therapy; Hemodialysis Clinical Trial
Official title:
A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Intravenously Administered SFP in Healthy Volunteers
The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of intravenously administered Soluble Ferric Pyrophosphate
- A total of 48 healthy volunteers will be studied.
- Depending on the safety profile at completion of the highest dose cohort, an additional
2 cohorts of subjects may be studied.
- Doses of SFP may be modified, depending on the PK and safety findings at each dose
level.
- Cohorts may be dropped for safety or tolerability after discussion with the sponsor.
- There will be 6 active and 2 placebo subjects in each study cohort.
- Subjects in Cohorts 1-3 will receive ascending doses of SFP by intravenous infusion
over 4 hours.
- Subjects in Cohorts 4-6 will receive ascending doses of SFP by intravenous infusion
over 12 hours.
All subjects will be confined in the CRC for 1 day prior to study drug administration and
for 2 additional days for safety assessments and completion of test procedures.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment