A Study to Evaluate BBI-001 in Healthy Volunteers and in Patients With Hereditary Hemochromatosis
Recruiting
Phase 1
Phase 2
Interventional Study
Hereditary Hemochromatosis
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 34 (estimated)
- Sponsor
- Bond Biosciences · Industry
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About This Trial
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) w…
Trial Locations
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Eligibility Criteria
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 othe…
Contacts