Safety of Larazotide Acetate in Healthy Volunteers

CLIN1001-003 was a Phase 1, randomized, double-blind, placebo controlled multi-dose study to determine the safety, tolerance, and pharmacokinetics (including food effect) of 3 dose levels of larazotide acetate in healthy volunteers. Three (3) cohorts of 8 subjects, in which six (6) subjects in each cohort received larazotide acetate in escalating doses of 0.25 mg, 1 mg, or 4 mg TID for 10 days and two (2) subjects received placebo TID for 10 days, were studied. Subjects maintained a standard gluten-free diet. Subjects were dosed three times a day 30 minutes prior to meals except for the morning dosing on Days 1, 5, and 10. For the morning dosing on Days 1, 5, and 10 subjects, fasted overnight prior to dosing and for 2 hours post dose. Subjects were evaluated for safety (medical history, physical examination, vital signs, clinical laboratory testing, and 12-lead electrocardiograms) throughout the study. Serial blood samples were collected or pharmacokinetic determinations at baseline and 2 hours post morning dose on Days 1, 2, 5, 6 and 10.