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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05238207

Enrollment

Registered

2022-02-14

Start date

2022-03-28

Completion date

2023-05-04

Last updated

2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Hemochromatosis

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.

Interventions

DRUGBBI-001

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

DIETARY_SUPPLEMENTOriginal Fibre Metamucil

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Evaluation of Iron Isotope Blood Levels	up to 17 days	Fe57 and Fe58 blood concentrations

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026