NCT05238207
Terminated
Phase 1
A Phase Ia/Ib Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BBI-001 in Iron Deficient Volunteers and HH Patients
Bond Biosciences1 site in 1 country24 target enrollmentMarch 28, 2022
Overview
- Phase
- Phase 1
- Intervention
- Original Fibre Metamucil
- Conditions
- Hereditary Hemochromatosis
- Sponsor
- Bond Biosciences
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Adverse Events (AE)
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a first in human, double-blind, randomized, placebo-controlled, two-arm crossover study evaluating the safety, tolerability and PD of ascending dose levels of BBI-001 after:
- a single administration in iron deficient male and female participants, and male and female HH patients (Part A),
- two administrations per day in HH patients (Part B). BBI-001 administrations will be accompanied with consumption of a meal enriched with stable iron isotope Fe57, while corresponding placebo dose administrations will be with a meal enriched with stable iron isotope Fe58.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Otherwise healthy iron deficient participants or patients with hereditary hemochromatosis
Exclusion Criteria
- •Serious or unstable medical or psychiatric conditions
- •Significant medical history
- •Current infections
- •Receiving iron chelation therapy or treatment other than stable maintenance phlebotomy for the prior 6 months
- •Organ damage from iron overload in the view of the PI would prevent successful completion of the protocol
Arms & Interventions
Placebo
Placebo: Oral administration immediately prior to a meal enriched with stable iron isotope Fe58
Intervention: Original Fibre Metamucil
BBI-001
BBI-001: Oral administration immediately prior to a meal enriched with stable iron isotope Fe57
Intervention: BBI-001
Outcomes
Primary Outcomes
Adverse Events (AE)
Time Frame: up to 17 days
Incidence, type, and severity of AEs, to include clinically significant laboratory changes
Clinical Laboratory Testing - Iron Panel
Time Frame: up to 17 days
Changes from baseline in iron panel
Secondary Outcomes
- Evaluation of Iron Isotope Blood Levels(up to 17 days)
Study Sites (1)
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