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

NCT07371793 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: BBI-001-102
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Hereditary Hemochromatosis

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AE)

  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

Study Arms (2)

BBI-001

EXPERIMENTAL

Drug: BBI-001

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

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.

BBI-001

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bond Biosciences: lead

Study Sites (1)

Clinical Research Unit

Sydney, New South Wales, 2031, Australia

Location

Related Links

• Sponsor website

MeSH Terms

Conditions

Hemochromatosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Curtis Scribner, MD

  Bond Biosciences

  STUDY CHAIR

Central Study Contacts

Georgina Kilfoil

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 28, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)