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news.KAI Pharmaceuticals has recruited first patient in KAI-4169 Phase 1b double-blind, randomised, placebo-controlled, crossover study to evaluate the safety and tolerability of single ascending doses of KAI-4169 in end-stage renal disease (ESRD) patients with secondary hyperparathyroidism (SHPT) undergoing hemodialysis.
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The study also is also expected to investigate the pharmacokinetics of KAI-4169 and its effect on parathyroid hormone (PTH) and serum calcium levels.
The data from Phase 1 trial suggested that KAI-4169 was safe and well-tolerated and confirmed the potency and activity of KAI-4169 by demonstrating dose-dependent reductions in PTH and serum calcium levels in healthy male subjects.
KAI Pharma president and CEO said that the initiation of testing in patients is a critical step in the progress of development program for KAI-4169.