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

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

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07371793

Enrollment

Registered

2026-01-28

Start date

2026-05-04

Completion date

2027-02-01

Last updated

2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Hemochromatosis

Brief summary

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.

Interventions

DRUGBBI-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.

OTHERPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Adverse Events (AE)	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

Countries

Australia

Contacts

CONTACTGeorgina Kilfoil

georgina@ashcroftlsc.com.au+61 (0)432 388 772

STUDY_CHAIRCurtis Scribner, MD

Bond Biosciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026