The Phase I clinical trial is an open label, dose determination study which will be conducted in the US with approximately 24 hemodialysis patients in two treatment cohorts. The first cohort will receive a single dose of 1mcg of CTAP201 injection and the second cohort will receive a single dose of either 0.5 or 3mcg, depending on the data obtained from the first cohort.
The pharmacokinetic profile of CTAP201 injection will be evaluated post-dosing in both cohorts. Safety endpoints in this study will include adverse events, physical and clinical laboratory assessments, and measurements of adjusted serum total calcium (Ca), serum phosphorus (P), and calculated serum Ca x P product.
Joel Melnick, vice president of clinical R&D at Cytochroma, said: In patients with secondary hyperparathyroidism (SHPT), the parathyroid glands produce and secrete excessive amounts of parathyroid hormone, ultimately causing bone softening and vascular tissue calcification. Additionally, a majority of chronic kidney disease (CKD) patients with SHPT are unable to reach the treatment goals established by the National Kidney Foundation as a result of hyperphosphatemia.
CTAP201 Injection may be a valuable alternative to current therapies for CKD patients as it has potent parathyroid hormone-lowering effects in preclinical CKD models with less effect on serum calcium and phosphorus.