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

May 12, 2026 updated by: Bond Biosciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2031
        • Recruiting
        • Clinical Research Unit
        • Contact:
          • Georgina Kilfoil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
In Part 1 placebo administered TID for 14 days. In Part 2 placebo administered TID for 3 days in a cross-over fashion.
Experimental: BBI-001
Drug: BBI-001
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bond Biosciences

Investigators

  • Study Chair: Curtis Scribner, MD, Bond Biosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBI-001-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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