Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07371793

A Study to Evaluate BBI-001 in Healthy Volunteers and in Patients With Hereditary Hemochromatosis

This study will be conducted in two parts run in parallel.

Part 1 of the study (Phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose) will enroll healthy volunteers in 3 sequential dose escalating cohorts with BBI-101 or placebo administered 3 times per day (TID) for 14 days.

Part 2 of the study (Phase 2a, randomized, multiple dose, two-period, two-sequence crossover) will evaluate the effect of BBI-001 on blood iron parameters in patients with hereditary hemochromatosis receiving 8 doses of BBI-001 or placebo treatment administered TID in Period 1 followed by administration of reverse treatment in Period 2. Dosing periods will be separated by 12 days.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hereditary Hemochromatosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hemochromatosis Iron Metabolism Disorders Iron Overload Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinical Research Unit

Sydney, New South Wales, 2031, Australia

Location status: Recruiting

Location contact

Georgina Kilfoil

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy volunteers (Part 1) or patients with hereditary hemochromatosis (Part 2)

Exclusion criteria

Serious or unstable medical or psychiatric conditions

Significant medical history

Current infections

Alcohol use disorder

Receiving iron chelation therapy or treatment other than stable maintenance phlebotomy for the prior 6 months (Part 2)

Organ damage from iron overload in the view of the principal investigator would prevent successful completion of the protocol (Part 2)

Treatment and study plan

BBI-001

Drug

In Part 1 BBI-001 administered TID for 14 days. In Part 2 BBI-001 administered TID for 3 days in a cross-over fashion.

Placebo

Other

In Part 1 placebo administered TID for 14 days. In Part 2 placebo administered TID for 3 days in a cross-over fashion.

Primary outcomes

  1. Adverse Events (AE)

    Time frame: Up to 30 days

    Incidence and severity of AEs and serious AEs (SAEs), including clinically significant abnormalities in physical examinations, vitals signs, ECG parameters, and laboratory results

Study contacts

Contact information is provided by the study sponsor or research team.

Georgina Kilfoil

CONTACT

[email protected]

+61 (0)432 388 772

Sponsors and collaborators

Lead sponsor

Bond Biosciences

Industry

Registry information

Official study title

A Phase 1/2a, Two-Part, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacodynamics of Multiple Doses of Oral BBI-001 in Healthy Participants and in Participants With Hereditary Hemochromatosis

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 28, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.