A Phase 1/2 interventional study of BBI-001 and Placebo in Hereditary Hemochromatosis, sponsored by Bond Biosciences. Recruiting at 1 site in Australia. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Bond Biosciences · Phase 1/2, Interventional, and Treatment
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.
55 studies on the registry are indexed under Hemochromatosis; 4 are open to participants now.
This study's planned enrollment of 34 is below the median of 61 across 30 interventional studies indexed under Hemochromatosis.
Browse Hemochromatosis studies →Bond Biosciences is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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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)
Drug: BBI-001
Other: Placebo
In Part 1 BBI-001 administered TID for 14 days. In Part 2 BBI-001 administered TID for 3 days in a cross-over fashion.
In Part 1 placebo administered TID for 14 days. In Part 2 placebo administered TID for 3 days in a cross-over fashion.
Adverse Events (AE)
Incidence and severity of AEs and serious AEs (SAEs), including clinically significant abnormalities in physical examinations, vitals signs, ECG parameters, and laboratory results
Time frame: Up to 30 days
Plan to share: No
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