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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05238207




Registration number
NCT05238207
Ethics application status
Date submitted
24/01/2022
Date registered
14/02/2022
Date last updated
2/08/2023

Titles & IDs
Public title
A Study to Evaluate BBI-001 in Hereditary Haemochromatosis (HH) Patients and Iron Deficient Volunteers
Scientific 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
Secondary ID [1] 0 0
BBI001-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hereditary Hemochromatosis 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BBI-001
Treatment: Other - Original Fibre Metamucil

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

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


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

Treatment: Other: Original Fibre Metamucil
Part A: 1 dose placebo administered in a crossover fashion Part B: 2 doses placebo administered in a crossover fashion
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events (AE)
Timepoint [1] 0 0
up to 17 days
Primary outcome [2] 0 0
Clinical Laboratory Testing - Iron Panel
Timepoint [2] 0 0
up to 17 days
Secondary outcome [1] 0 0
Evaluation of Iron Isotope Blood Levels
Timepoint [1] 0 0
up to 17 days

Eligibility
Key inclusion criteria
* Otherwise healthy iron deficient participants or patients with hereditary hemochromatosis
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/05/2023
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Networks - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bond Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05238207
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Curtis Scribner, MD
Address 0 0
Sponsor GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05238207