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

NCT05238207 | Terminated Phase 1 DMC

• 1 other identifier: BBI001-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hereditary Hemochromatosis

Outcome Measures

Primary Outcomes (2)

• Adverse Events (AE)

  Incidence, type, and severity of AEs, to include clinically significant laboratory changes

  up to 17 days

• Clinical Laboratory Testing - Iron Panel

  Changes from baseline in iron panel

  up to 17 days

Secondary Outcomes (1)

• Evaluation of Iron Isotope Blood Levels

  up to 17 days

Study Arms (2)

BBI-001

EXPERIMENTAL

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

Drug: BBI-001

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Original Fibre Metamucil

Interventions

BBI-001 DRUG

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

BBI-001

Original Fibre Metamucil DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Otherwise healthy iron deficient participants or patients with hereditary hemochromatosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Bond Biosciences: lead

Study Sites (1)

Nucleus Networks

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Hemochromatosis

Condition Hierarchy (Ancestors)

Metal Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Iron Overload; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Curtis Scribner, MD

  Sponsor GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 14, 2022
• Study Start: March 28, 2022
• Primary Completion: May 4, 2023
• Study Completion: May 4, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)