A Study to Evaluate BBI-001 in Hereditary Haemochromatosis (HH) Patients and Iron Deficient Volunteers
Status:
Not yet recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
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.