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

August 1, 2023 updated by: Bond Biosciences

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Nucleus Networks

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BBI-001
BBI-001: Oral administration immediately prior to a meal enriched with stable iron isotope Fe57
Drug: BBI-001
Part A: 1 dose BBI-001 administered in a crossover fashion Part B: 2 doses BBI-001 administered in a crossover fashion
Placebo Comparator: Placebo
Placebo: Oral administration immediately prior to a meal enriched with stable iron isotope Fe58
Dietary supplement: Original Fibre Metamucil
Part A: 1 dose placebo administered in a crossover fashion Part B: 2 doses placebo administered in a crossover fashion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AE)
Time Frame: up to 17 days
Incidence, type, and severity of AEs, to include clinically significant laboratory changes
up to 17 days
Clinical Laboratory Testing - Iron Panel
Time Frame: up to 17 days
Changes from baseline in iron panel
up to 17 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bond Biosciences

Investigators

  • Study Chair: Curtis Scribner, MD, Sponsor GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Actual)

May 4, 2023

Study Completion (Actual)

May 4, 2023

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

February 11, 2022

First Posted (Actual)

February 14, 2022

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBI001-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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