Fig. 2

Trial design. This was a double blind, placebo controlled, intrasubject cross over, single ascending dose escalation study. Four subjects with iron deficiency were enrolled in each cohort and randomized 3:1 to receive BBI-001 or Metamucil placebo. Each subject received BBI-001 or placebo on Day 1 and then returned at least 1 week later to receive the alternate treatment. After at least 8 h of fasting, each subject received a low iron breakfast supplemented with Fe⁵⁷ if given BBI-001 or Fe⁵⁸ if given placebo.