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

NCT ID: NCT05238207

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2023-05-04

Brief 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.

Conditions

Hereditary Hemochromatosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BBI-001

BBI-001: Oral administration immediately prior to a meal enriched with stable iron isotope Fe57

Group Type: EXPERIMENTAL

BBI-001

Intervention Type: DRUG

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

Placebo

Placebo: Oral administration immediately prior to a meal enriched with stable iron isotope Fe58

Group Type: PLACEBO_COMPARATOR

Original Fibre Metamucil

Intervention Type: DIETARY_SUPPLEMENT

Part A: 1 dose placebo administered in a crossover fashion Part B: 2 doses placebo administered in a crossover fashion

Interventions

BBI-001

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

Intervention Type: DRUG

Original Fibre Metamucil

Part A: 1 dose placebo administered in a crossover fashion Part B: 2 doses placebo administered in a crossover fashion

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bond Biosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Curtis Scribner, MD

Role: STUDY_CHAIR

Sponsor GmbH

Locations

Nucleus Networks

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

BBI001-101

Identifier Type: -

Identifier Source: org_study_id