A Phase 1/2a, Two-Part, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacodynamics of Multiple Doses of Oral BBI-001 in Healthy Participants and in Participants With Hereditary Hemochromatosis
This study will be conducted in two parts run in parallel. Part 1 of the study (Phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose) will enroll healthy volunteers in 3 sequential dose escalating cohorts with BBI-101 or placebo administered 3 times per day (TID) for 14 days. Part 2 of the study (Phase 2a, randomized, multiple dose, two-period, two-sequence crossover) will evaluate the effect of BBI-001 on blood iron parameters in patients with hereditary hemochromatosis receiving 8 doses of BBI-001 or placebo treatment administered TID in Period 1 followed by administration of reverse treatment in Period 2. Dosing periods will be separated by 12 days.
• Healthy volunteers (Part 1) or patients with hereditary hemochromatosis (Part 2)