A Phase 1 interventional study of FBS0701 in Transfusional Iron Overload and Beta-thalassemia, sponsored by FerroKin BioSciences, Inc.. Completed at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-10.
Sponsored by FerroKin BioSciences, Inc. · Phase 1, Interventional, and Treatment
The purpose of this research study is to study the safety of increasing doses of FBS0701, and to see how quickly the study medication is absorbed and how quickly it disappears from the bloodstream. FBS0701 is a new, oral iron chelator - a medication taken by mouth that increases the body's elimination of iron. Iron chelators are used in patients who develop iron overload from their transfusions. Four increasing doses of FBS0701 will be tested during this study. The study will start with the lowest dose given to 4 patients (3 mg/kg/day. The next group of 4 patients will receive the next high dose (8mg/kg/day only after the results of the first 4 patients are examined and it is determined safe to continue. Participating patients will take the study medication for 7 days and be followed for 28 days after their last dose to determine if they have any reactions to the study medication - therefore a total of 35 days on study. Patients will need to give up to 17 blood samples over the screening period and first 15 days of the study (a total of about 9 tablespoons). Patients will not need to stay overnight in the clinic but will need to visit the clinic 10 times for screening and on-study visits over the 35 days. Patients currently taking an iron chelator will need to stop that treatment for up to 22 days (up to 5 days before they start the study and for 15 days during the study). The results of this study will be helpful in determining the safety of the drug and the best doses of FBS0701 to be used in the next study which will assess the effectiveness of this new iron chelator.
416 studies on the registry are indexed under Thalassemia; 67 are open to participants now.
This study's enrollment of 20 is below the median of 37 across 277 interventional studies indexed under Thalassemia.
Browse Thalassemia studies →This is the only study on the registry with FerroKin BioSciences, Inc. as lead sponsor.
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Exclusion Criteria:
5 escalating doses of FBS0701 in 5 cohorts of 4 patients each.
Drug: FBS0701
Oral FBS0701 for 7 days at one of the following doses: 3 mg/kg/day or 8 mg/kg/day or 16 mg/kg/day or 32 mg/kg/day or 40 mg/kg/day
Safety and tolerability by AEs, Physical Exam, Clinical Laboratory assessments
Time frame: 35 days (7 days treatment and 28 days follow up)
Steady state plasma level and half-life of FBS0701
Time frame: 7 days of dosing
Urinary excretion of iron
Time frame: 7 days of dosing
This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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