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: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bond Biosciences
• Treatments: Psyllium

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