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.

NCT Number	NCT07371793
Lead Sponsor	Bond Biosciences
Conditions	Hereditary Hemochromatosis
Enrollment	34 participants
Start Date	2026-05-04
Primary Completion	2027-02 (estimated)
Study Completion	2027-02 (estimated)
Updated on ClinicalTrials.gov	2026-05-13