A Study to Evaluate BBI-001 in Hereditary Haemochromatosi... | NCT05238207

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

NCT05238207

Sponsor

Bond Biosciences

Status

Terminated

Last Update Posted

Aug 2, 2023Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Hereditary Hemochromatosis

Interventions

BBI-001
Original Fibre Metamucil

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Only Part A (single dosing) was conducted due to business considerations

Expanded Access Info

Start Date

Mar 28, 2022Actual

Primary Completion Date

May 4, 2023Actual

Completion Date

May 4, 2023Actual

First Submitted Date

Jan 24, 2022

First Submission Date that Met QC Criteria

Feb 11, 2022

First Posted Date

Feb 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2023

Last Update Posted Date

Aug 2, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Curtis Scribner, MD	Sponsor GmbH	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nucleus Networks		Melbourne	Victoria	3004	Australia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006432	Hemochromatosis

Ancestor Terms

ID	Term
D008664	Metal Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided