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

Bond Biosciences

Status and phase: Begins enrollment this month; Phase 2; Phase 1

Conditions: Hereditary Hemochromatosis

Treatments: Drug: BBI-001; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07371793

BBI-001-102

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups, including a placebo group

BBI-001

Experimental group

Treatment:

Drug: BBI-001

Placebo

Placebo Comparator group

Treatment:

Other: Placebo