Back to resultsA Study to Evaluate BBI-001 in Hereditary Haemochromatosis (HH) Patients and Iron Deficient Volunteers
Primary Purpose
Hereditary Hemochromatosis
Status
Terminated
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
BBI-001
Original Fibre Metamucil
Sponsored by
About this trial
This is an interventional treatment trial for Hereditary Hemochromatosis
Eligibility Criteria
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
Sites / Locations
- Nucleus Networks
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BBI-001
Placebo
Arm Description
BBI-001: Oral administration immediately prior to a meal enriched with stable iron isotope Fe57
Placebo: Oral administration immediately prior to a meal enriched with stable iron isotope Fe58
Outcomes
Primary Outcome Measures
Adverse Events (AE)
Incidence, type, and severity of AEs, to include clinically significant laboratory changes
Clinical Laboratory Testing - Iron Panel
Changes from baseline in iron panel
Secondary Outcome Measures
Evaluation of Iron Isotope Blood Levels
Fe57 and Fe58 blood concentrations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05238207
Brief Title
A Study to Evaluate BBI-001 in Hereditary Haemochromatosis (HH) Patients and Iron Deficient Volunteers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Only Part A (single dosing) was conducted due to business considerations
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
May 4, 2023 (Actual)
Study Completion Date
May 4, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bond Biosciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Hemochromatosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BBI-001
Arm Type
Experimental
Arm Description
BBI-001: Oral administration immediately prior to a meal enriched with stable iron isotope Fe57
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo: Oral administration immediately prior to a meal enriched with stable iron isotope Fe58
Intervention Type
Drug
Intervention Name(s)
BBI-001
Intervention Description
Part A: 1 dose BBI-001 administered in a crossover fashion Part B: 2 doses BBI-001 administered in a crossover fashion
Intervention Type
Dietary Supplement
Intervention Name(s)
Original Fibre Metamucil
Intervention Description
Part A: 1 dose placebo administered in a crossover fashion Part B: 2 doses placebo administered in a crossover fashion
Primary Outcome Measure Information:
Title
Adverse Events (AE)
Description
Incidence, type, and severity of AEs, to include clinically significant laboratory changes
Time Frame
up to 17 days
Title
Clinical Laboratory Testing - Iron Panel
Description
Changes from baseline in iron panel
Time Frame
up to 17 days
Secondary Outcome Measure Information:
Title
Evaluation of Iron Isotope Blood Levels
Description
Fe57 and Fe58 blood concentrations
Time Frame
up to 17 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Curtis Scribner, MD
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Chair
Facility Information:
Facility Name
Nucleus Networks
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate BBI-001 in Hereditary Haemochromatosis (HH) Patients and Iron Deficient Volunteers
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