Spectrum Pharmaceuticals (SPPI) Begins Enrollment n RenaZorb Phase 1
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Spectrum Pharmaceuticals (Nasdaq: SPPI), announced the initiation of patient enrollment in a Phase 1 clinical trial evaluating the safety and tolerability of RenaZorb (also referred to as SPI-014) in healthy volunteers. RenaZorb is a lanthanum-based nanotechnology compound with potent phosphate-binding properties.
The double-blind, dose-ranging, Phase 1 study in healthy volunteers is designed to evaluate the safety and the phosphate-binding capacity of RenaZorb. The primary endpoint is capacity to bind phosphorous ingested with food, evaluated by comparing the difference in urine and fecal phosphorus levels measured before and after RenaZorb dosing. Secondary endpoints are safety and tolerability along with measurements of serum lanthanum levels. The study is expected to enroll 32 healthy volunteers into four sequential dose cohorts of eight subjects each. Six subjects will be randomly assigned to receive RenaZorb and two subjects to receive placebo within each cohort. RenaZorb will be taken orally three times a day within 15 minutes after meals in all four cohorts (1500 mg/day, 3000 mg/day, 4500 mg/day and 6000 mg/day). Renal excretion of phosphate is expected to decrease and fecal excretion of phosphate is expected to increase after RenaZorb dosing.
The double-blind, dose-ranging, Phase 1 study in healthy volunteers is designed to evaluate the safety and the phosphate-binding capacity of RenaZorb. The primary endpoint is capacity to bind phosphorous ingested with food, evaluated by comparing the difference in urine and fecal phosphorus levels measured before and after RenaZorb dosing. Secondary endpoints are safety and tolerability along with measurements of serum lanthanum levels. The study is expected to enroll 32 healthy volunteers into four sequential dose cohorts of eight subjects each. Six subjects will be randomly assigned to receive RenaZorb and two subjects to receive placebo within each cohort. RenaZorb will be taken orally three times a day within 15 minutes after meals in all four cohorts (1500 mg/day, 3000 mg/day, 4500 mg/day and 6000 mg/day). Renal excretion of phosphate is expected to decrease and fecal excretion of phosphate is expected to increase after RenaZorb dosing.
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