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

Bond Biosciences

Status and phase: Terminated; Phase 1

Conditions: Hereditary Hemochromatosis

Treatments: Dietary Supplement: Original Fibre Metamucil; Drug: BBI-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT05238207

BBI001-101

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

BBI-001

Experimental group

Description:

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

Treatment:

Drug: BBI-001

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Original Fibre Metamucil