NCT01920854

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Rockwell Medical Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Kidney Failure, Chronic Therapy; Hemodialysis

Interventions

Type	Name	Description
DRUG	soluble ferric pyrophosphate
DRUG	Placebo

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2013-08-12
• Last updated: 2015-01-26
• Results posted: 2014-12-19

Locations

1 site across 1 country: United States