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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Part A: 1 dose BBI-001 administered in a crossover fashion Part B: 2 doses BBI-001 administered in a crossover fashion
Part A: 1 dose placebo administered in a crossover fashion Part B: 2 doses placebo administered in a crossover fashion
Nucleus Networks
Melbourne, Victoria, Australia
Adverse Events (AE)
Incidence, type, and severity of AEs, to include clinically significant laboratory changes
Time frame: up to 17 days
Clinical Laboratory Testing - Iron Panel
Changes from baseline in iron panel
Time frame: up to 17 days
Evaluation of Iron Isotope Blood Levels
Fe57 and Fe58 blood concentrations
Time frame: up to 17 days
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