A Study to Evaluate BBI-001 in Healthy Volunteers and in Patients 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.

Inclusion Criteria: Healthy volunteers (Part 1) or patients with hereditary hemochromatosis (Part 2) Exclusion Criteria: Serious or unstable medical or psychiatric conditions Significant medical history Current infections Alcohol use disorder Receiving iron chelation therapy or treatment other than stable maintenance phlebotomy for the prior 6 months (Part 2) Organ damage from iron overload in the view of the principal investigator would prevent successful completion of the protocol (Part 2)