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

Sponsor

Bond Biosciences (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05238207

Collaborator

(none)

Enrollment

Location

Arms

6.1

Anticipated Duration (Months)

8.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hereditary Hemochromatosis	Drug: BBI-001 Dietary Supplement: Original Fibre Metamucil	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 28, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluation of Iron Isotope Blood Levels [up to 17 days]
Fe57 and Fe58 blood concentrations

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nucleus Networks	Melbourne	Victoria	Australia	3004

Sponsors and Collaborators

Bond Biosciences

Investigators

Study Chair: Curtis Scribner, MD, Sponsor GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bond Biosciences

ClinicalTrials.gov Identifier:

NCT05238207

Other Study ID Numbers:

BBI001-101

First Posted:

Feb 14, 2022

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hemochromatosis

Hemosiderosis

Psyllium

Study Results

No Results Posted as of Jul 20, 2022