Status:
TERMINATED
A Study to Evaluate BBI-001 in Hereditary Haemochromatosis (HH) Patients and Iron Deficient Volunteers
Lead Sponsor:
Bond Biosciences
Conditions:
Hereditary Hemochromatosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a first in human, double-blind, randomized, placebo-controlled, two-arm crossover study evaluating the safety, tolerability and PD of ascending dose levels of BBI-001 after: * a single admini...
Eligibility Criteria
Inclusion
- Otherwise healthy iron deficient participants or patients with hereditary hemochromatosis
Exclusion
- Serious or unstable medical or psychiatric conditions
- Significant medical history
- Current infections
- Receiving iron chelation therapy or treatment other than stable maintenance phlebotomy for the prior 6 months
- Organ damage from iron overload in the view of the PI would prevent successful completion of the protocol
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05238207
Start Date
March 28 2022
End Date
May 4 2023
Last Update
August 2 2023
Active Locations (1)
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1
Nucleus Networks
Melbourne, Victoria, Australia, 3004