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

Hereditary Hemochromatosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05238207
• Other study ID #: BBI001-101
• Status: Terminated
• Phase: Phase 1
• Start date: March 28, 2022
• Est. completion date: May 4, 2023

Study information

• Verified date: August 2023
• Source: Bond Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: May 4, 2023
• Est. primary completion date: May 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemochromatosis
• Hemosiderosis
• Hereditary Hemochromatosis

Intervention

Drug:
• BBI-001
Part A: 1 dose BBI-001 administered in a crossover fashion Part B: 2 doses BBI-001 administered in a crossover fashion

Dietary Supplement:
• Original Fibre Metamucil
Part A: 1 dose placebo administered in a crossover fashion Part B: 2 doses placebo administered in a crossover fashion

Locations

Country	Name	City	State
Australia	Nucleus Networks	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Bond Biosciences

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events (AE)	Incidence, type, and severity of AEs, to include clinically significant laboratory changes	up to 17 days
Primary	Clinical Laboratory Testing - Iron Panel	Changes from baseline in iron panel	up to 17 days
Secondary	Evaluation of Iron Isotope Blood Levels	Fe57 and Fe58 blood concentrations	up to 17 days