Hereditary HemochromatosisPhase 1NCT05238207
A Study to Evaluate BBI-001 in Hereditary Haemochromatosis (HH) Patients and Iron Deficient Volunteers
A Phase 1 study testing BBI-001 and Original Fibre Metamucil in people with Hereditary Hemochromatosis, run by Bond Biosciences at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hereditary Hemochromatosis
- What is being tested?
- BBI-001 and Original Fibre Metamucil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Mar 2022to 4 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Otherwise healthy iron deficient participants or patients with hereditary hemochromatosis
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- BBI-001, Original Fibre Metamucil
- Medical subject headings
- Hemochromatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBI-001Drug
Part A: 1 dose BBI-001 administered in a crossover fashion Part B: 2 doses BBI-001 administered in a crossover fashion
Original Fibre MetamucilDietary supplement
Part A: 1 dose placebo administered in a crossover fashion Part B: 2 doses placebo administered in a crossover fashion
| Study group | Role | What they receive |
|---|---|---|
| BBI-001 | Experimental | BBI-001: Oral administration immediately prior to a meal enriched with stable iron isotope Fe57 Receives: Drug: BBI-001 |
| Placebo | Placebo comparator | Placebo: Oral administration immediately prior to a meal enriched with stable iron isotope Fe58 Receives: Dietary Supplement: Original Fibre Metamucil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE)
Incidence, type, and severity of AEs, to include clinically significant laboratory changes
Measured: up to 17 days
Clinical Laboratory Testing - Iron Panel
Changes from baseline in iron panel
Measured: up to 17 days
Secondary outcomes (1)
Evaluation of Iron Isotope Blood Levels
Fe57 and Fe58 blood concentrations
Measured: up to 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start28 Mar 2022
- Primary completion4 May 2023
- Study completion4 May 2023
Why it stopped: Only Part A (single dosing) was conducted due to business considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary HemochromatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bond Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Curtis Scribner, MD, Study chair, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238207
- Sponsor's protocol ID
- BBI001-101
- Status last verified
- Aug 2023
- First submitted
- 24 Jan 2022
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05238207
- Acronym / sponsor ID
- BBI001-101
- Conditions
- Hereditary Hemochromatosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only Part A (single dosing) was conducted due to business considerations
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bond BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BBI-001 | Experimental | Drug: BBI-001BBI-001: Oral administration immediately prior to a meal enriched with stable iron isotope Fe57 |
| Placebo | Placebo comparator | Dietary Supplement: Original Fibre MetamucilPlacebo: Oral administration immediately prior to a meal enriched with stable iron isotope Fe58 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Otherwise healthy iron deficient participants or patients with hereditary hemochromatosis
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBI-001Part A: 1 dose BBI-001 administered in a crossover fashion Part B: 2 doses BBI-001 administered in a crossover fashion | Drug | BBI-001 |
| Original Fibre MetamucilPart A: 1 dose placebo administered in a crossover fashion Part B: 2 doses placebo administered in a crossover fashion | Dietary supplement | Placebo |
Primary outcome
Adverse Events (AE)
Time frame: up to 17 days
Incidence, type, and severity of AEs, to include clinically significant laboratory changes
Clinical Laboratory Testing - Iron Panel
Time frame: up to 17 days
Changes from baseline in iron panel
1 secondary outcome
Evaluation of Iron Isotope Blood Levels
Time frame: up to 17 days
Results and safety
The study was stopped early (reason given: Only Part A (single dosing) was conducted due to business considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Curtis Scribner, MD study chair
Sponsor GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BBI-001 and Original Fibre Metamucil in people with Hereditary Hemochromatosis, run by Bond Biosciences at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Only Part A (single dosing) was conducted due to business considerations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AE) (time frame: up to 17 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.