[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.