A Phase 1 interventional study of Hemin infusion and placebo infusion in Healthy Volunteers, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-04-17.
Sponsored by Mayo Clinic · Phase 1 and Interventional
This study is being done because we want to learn if hemin can increase the production of heme oxygenase 1. Heme oxygenase 1 (HO-1) is an enzyme which protects cells from physical, chemical, and biologic stress. Hemin is produced from red blood cells and is approved by the Food and Drug Administration for treating acute porphyria, which is an inherited condition caused by an enzyme deficiency.
Heme-oxygenase 1 (HO-1) degrades heme, protects cells against oxidative stress, and is beneficial in several experimental models but has not been pharmacologically activated in humans. The objectives of this study were to evaluate the effects of hemin on HO-1 activity in healthy subjects. Hemin is the most powerful inducer of HO-1. Hemin is FDA-approved to treat acute intermittent porphyria. In addition, hemin has also been used to treat thalassemia intermedia, myelodysplastic syndrome, and to control liver allograft failure due to recurrence of erythropoietic prototheria. Our hypothesis is that compared to placebo, hemin will increase HO-1 in humans. Ten healthy subjects will be randomized to hemin (n = 5, Panhematin®, Ovation Pharmaceuticals, 3 mg/kg i.v. in 25% albumin) or placebo (n = 5, 25% albumin) infusion. HO-1 activity will be assessed before and after (4, 6, 24, and 48 hours) infusions.
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Drug: Hemin infusion
Drug: placebo infusion
Hemin (Panhematin®, Ovation Pharmaceuticals, Deerfield, IL) will be administered through a large-caliber peripheral vein at a dose of 1.25 mL/kg and at a rate of 60 mL/hour. To enhance stability, Panhematin® will be diluted in \~ 132 mL of 25% albumin to obtain a hemin concentration of 2.4 mg/mL.
25 % albumin will be administered through a large-caliber peripheral vein at a dose at a rate of 60 mL/hour.
Venous carboxyhemoglobin concentrations
Time frame: at 6 hours
HO-1 protein concentration in leukocytes from venous blood
Time frame: at 6 hours
Serum bilirubin
Time frame: at 6 hours
Venous carboxyhemoglobin concentrations
Time frame: at 4, 24, and 48 hours
HO-1 activity in leukocytes from venous blood
Time frame: at 4, 24, and 48 hours
Serum bilirubin
Time frame: at 4, 24, and 48 hours
This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.
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