NCT05238207

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

Terminated Phase 1 Last updated 2 August 2023

What this trial tests

Phase 1 trial testing BBI-001 in Hereditary Hemochromatosis in 24 participants. Terminated before completion.

Timeline

28 March 2022

Primary endpoint
4 May 2023

4 May 2023

Quick facts

Lead sponsor	Bond Biosciences
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	24
Start date	28 March 2022
Primary completion	4 May 2023
Estimated completion	4 May 2023
Sites	1 location across Australia

Drugs / interventions tested

• BBI-001 — full drug profile →
• Original Fibre Metamucil

Conditions studied

• Hereditary Hemochromatosis — all drugs for Hereditary Hemochromatosis →

Sponsor

Bond Biosciences — full company profile →

Who can join

Adults 18 to 65, any sex, with Hereditary Hemochromatosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A phase 1b randomised clinical trial evaluating BBI-001, a non-absorbed oral therapeutic for the treatment of iron overload.
   Scribner C, Cope J, Ryan P, Olynyk JK, et al · · 2025 · PMID 40382392 · DOI 10.1038/s41598-025-01421-4