CompletedPhase 1ACTRN12609000213246

Safety study of a test oral iron chelator in male iron-overloaded patients

A Dose-Escalation, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of FBS0701 in Iron-Overloaded Male Patients

Sponsor

FerroKin BioSciences Inc.

Enrollment

4 participants

Start Date

May 1, 2009

Study Type

Interventional

Conditions

Iron overload in transfusion-dependent patients

Summary

This aim of this study is to assess the safety of different doses of anovel orally-administered iron chelator in patients with iron-overload.

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This is a safety study of a new oral medication designed to remove excess iron from the body. It is for males aged 18 to 50 who need regular blood transfusions and have iron overload. Participation involves stopping current iron-removal medication, taking the study drug, and having blood and urine tests to monitor safety.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Single dose (6 mg/kg, 10 mg/kg, 16 mg/kg or 32 mg/kg) of FBS0701 administered orally

Locations(1)

Australia

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ACTRN12609000213246