Actively Recruiting
A Study to Evaluate BBI-001 in Healthy Volunteers and in Patients With Hereditary Hemochromatosis
Led by Bond Biosciences · Updated on 2026-05-13
34
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate BBI-001 in Healthy Volunteers and in Patients With Hereditary Hemochromatosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers (Part 1) or patients with hereditary hemochromatosis (Part 2)
You will not qualify if you...
- Serious or unstable medical or psychiatric conditions
- Significant medical history
- Current infections
- Alcohol use disorder
- Receiving iron chelation therapy or treatments other than stable maintenance phlebotomy for the prior 6 months (Part 2)
- Organ damage from iron overload that would prevent successful completion of the protocol (Part 2)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clinical Research Unit
Sydney, New South Wales, Australia, 2031
Actively Recruiting
Research Team
G
Georgina Kilfoil
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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