TerminatedPhase 1

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

Stopped: Only Part A (single dosing) was conducted due to business considerations

Australia24 participantsStarted 2022-03-28

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Adverse Events (AE)

Timeframe: up to 17 days

Clinical Laboratory Testing - Iron Panel

Timeframe: up to 17 days

Trial details

NCT IDNCT05238207

SponsorBond Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-04

View on ClinicalTrials.gov More Hereditary Hemochromatosis trials