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

NCT05238207 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-08-02

No results posted yet for this study

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.

Conditions

  • Hereditary Hemochromatosis

Interventions

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

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

Sponsors & Collaborators

  • Bond Biosciences

    lead INDUSTRY

Principal Investigators

  • Curtis Scribner, MD · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2023-05-04
Completion
2023-05-04

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05238207 on ClinicalTrials.gov