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Clinical Trials associated with MT-1013[14C]MT1013在中国成年男性健康参与者和慢性肾脏病维持性血液透析合并继发性甲状旁腺功能亢进参与者体内的物质平衡研究
[Translation] Study on the balance of [14C]MT1013 in healthy Chinese adult male participants and participants with chronic kidney disease undergoing maintenance hemodialysis and secondary hyperparathyroidism
评价男性健康参与者和慢性肾脏病维持性血液透析合并继发性甲状旁腺功能亢进参与者静脉注射[14C]MT1013后人体放射性总回收率、排泄率数据、主要排泄途径、鉴定主要代谢产物,确定MT1013的代谢途径及消除途径;获得血浆总放射性的药代动力学参数,考察全血和血浆中总放射性的分配情况;评估单次静脉给[14C]MT1013后的安全性。
[Translation] Objective: To evaluate the total recovery rate of radioactivity, excretion rate data, major excretion pathways, and identification of major metabolites of [14C]MT1013 after intravenous administration in healthy male participants and participants with chronic kidney disease undergoing maintenance hemodialysis and secondary hyperparathyroidism, and to determine the metabolic and elimination pathways of MT1013. To obtain pharmacokinetic parameters of total plasma radioactivity and investigate the distribution of total radioactivity between whole blood and plasma. To evaluate the safety of a single intravenous administration of [14C]MT1013.
A Multicenter, Randomized, Double-blind, Double-dummy, Phase III Study to Evaluate the Efficacy and Safety of MT1013 Versus Cinacalcet as Active Control in Secondary Hyperparathyroidism Patients on Maintenance Dialysis
MT1013 is a first-in-class dual-target agonist. This study is a multicenter, randomized, double-blind, double-dummy phase III clinical study being conducetd to evaluate the efficacy and safety of MT1013 compared with active control cinacalcet in secondary hyperparathyroidism patients on maintenance dialysis. Subjects will be 1:1 randomized to receive MT1013 or cinacalcet for 26 weeks. Evaluations of iPTH, Ca, P, BMD, and biomarkers will be done across the study period, to compare efficacy and safety of MT1013 to cinacalcet.
A Multicenter, Randomized,Positive Controlled, and Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of MT1013 Injection in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Undergoing Maintenance Hemodialysis
This is a randomized, positive controlled, and placebo-controlled phase II clinical study to evaluate the efficacy and safety of MT1013 injection in the treatment of chronic kidney disease with secondary hyperparathyroidism (SHPT) undergoing maintenance hemodialysis (MHD) subjects.
100 Clinical Results associated with MT-1013
100 Translational Medicine associated with MT-1013
100 Patents (Medical) associated with MT-1013
100 Deals associated with MT-1013