多中心、开放、多次给药评价注射用 STSP-0601 在不伴抑制物血友病患者中的安全性及初步有效性的 II 期临床研究
[Translation] A multicenter, open-label, multiple-dose Phase II clinical study to evaluate the safety and preliminary efficacy of STSP-0601 for injection in patients with hemophilia without inhibitors
主要目的:评价注射用 STSP-0601 不同剂量、多次给药用于不伴抑制物血友病患者的安全性及出血事件按需治疗的初步有效性,为 III 期临床试验的给药方案提供依据。
次要目的:评价注射用 STSP-0601 不同剂量、多次给药在不伴抑制物血友病患者中的药效动力学和药代动力学特征。
[Translation] Primary objective: To evaluate the safety of different doses and multiple administrations of STSP-0601 for injection in patients with hemophilia without inhibitors and the preliminary effectiveness of on-demand treatment of bleeding events, and to provide a basis for the dosing regimen of Phase III clinical trials.
Secondary objective: To evaluate the pharmacodynamic and pharmacokinetic characteristics of different doses and multiple administrations of STSP-0601 for injection in patients with hemophilia without inhibitors.
随机、双盲、安慰剂对照评价注射用凝血因子X激活剂单次给药在健康志愿者中的安全性和耐受性的Ⅰ期临床研究
[Translation] A randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety and tolerability of a single dose of factor X activator for injection in healthy volunteers
本试验的目的是评价注射用凝血因子X激活剂单次给药在健康受试者中的安全性、耐受性,并考察其对健康受试者凝血功能的影响
[Translation] The purpose of this study is to evaluate the safety and tolerability of a single dose of factor X activator for injection in healthy subjects and to investigate its effect on coagulation function in healthy subjects.
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