Spectrum Pharmaceuticals has started patient enrollment for a Phase I clinical study to assess the tolerability and safety of a lanthanum-based nanotechnology compound named RenaZorb, which has strong phosphate-binding properties.
The Phase 1 study of RenaZorb is a double-blind, dose-ranging trial in healthy volunteers to assess the phosphate-binding capacity and safety of the lanthanum-based nanotechnology compound. The main endpoint of the study is to evaluate the phosphorous-binding capacity by comparing the variation in phosphorus levels in fecal and urine prior to and after the dosing of RenaZorb.
Other endpoints of the trial are to evaluate the tolerability and safety of RenaZorb and to measure serum lanthanum levels. Thirty two healthy volunteers are expected to participate in the study, which will comprise four sequential dose cohorts with eight subjects each. Six subjects will receive RenaZorb arbitrarily and remaining two subjects will get placebo.
All four cohorts, which include 6000 mg/day, 4500 mg/day, 3000 mg/day and 1500 mg/day), will take RenaZorb orally three times in a day inside 15 minutes after consuming meals. Following the dosing of RenaZorb, it is anticipated that phosphate fecal excretion will increase and phosphate renal excretion rate will decrease.
Spectrum Pharmaceuticals’ Chairman, President and Chief Executive Officer, Rajesh C. Shrotriya stated that the company is happy to start RenaZorb’s first human clinical trial on the basis of prior positive results. In vitro study demonstrated the superior phosphate-binding capacity of RenaZorb. The company expects that it can offer the same level of phosphate-binding capacity at a smaller tablet size and lower dose, thus enhancing patient tolerability.