A Study to Evaluate BBI-001 in Hereditary Haemochromatosis (HH) Patients and Iron Deficient Volunteers

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.

Timeline

Start

2022-03-28

Primary completion

2023-05-04

Completion

2023-05-04

Outcome

Outcome not reported

Stopped (Business): “Only Part A (single dosing) was conducted due to business considerations”

Drugs

Indications