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

Phase 1

Terminated

• Conditions: Hereditary Hemochromatosis
• Interventions: Drug: BBI-001; Dietary Supplement: Original Fibre Metamucil

• Registration Number: NCT05238207
• Lead Sponsor: Bond Biosciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-02-11
• Study First Posted: 2022-02-14
• Study Start: 2022-03-28
• Primary Completion: 2023-05-04
• Study Completion: 2023-05-04
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BBI-001	BBI-001	BBI-001: Oral administration immediately prior to a meal enriched with stable iron isotope Fe57
Placebo	Original Fibre Metamucil	Placebo: Oral administration immediately prior to a meal enriched with stable iron isotope Fe58

Primary Outcome Measures

Name	Time	Method
Adverse Events (AE)	up to 17 days	Incidence, type, and severity of AEs, to include clinically significant laboratory changes
Clinical Laboratory Testing - Iron Panel	up to 17 days	Changes from baseline in iron panel

Secondary Outcome Measures

Name	Time	Method
Evaluation of Iron Isotope Blood Levels	up to 17 days	Fe57 and Fe58 blood concentrations

Trial Locations

Locations (1)

Nucleus Networks; 🇦🇺 Melbourne, Victoria, Australia