[Translation] A multicenter, open-label, positive-controlled Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SYH9016 injection alone in participants with prostate cancer who are suitable for endocrine therapy
主要目的:Stage I:评价SYH9016注射液单次给药的安全性和耐受性;Stage II:评价SYH9016注射液多次给药的安全性和耐受性;确定SYH9016注射液的推荐剂量。次要目的:Stage I:比较SYH9016注射液各剂量组与醋酸亮丙瑞林微球注射液单次给药在适合内分泌治疗的前列腺癌患者中的药代动力学特征;比较SYH9016注射液各剂量组与醋酸亮丙瑞林微球注射液单次给药在适合内分泌治疗的前列腺癌患者中的药效学特征;Stage II:比较SYH9016注射液与醋酸亮丙瑞林微球注射液多次给药在适合内分泌治疗的前列腺癌中的药代动力学特征;比较SYH9016注射液与醋酸亮丙瑞林微球注射液多次给药在适合内分泌治疗的前列腺癌患者中的药效学特征;评价SYH9016注射液在适合内分泌治疗的前列腺癌患者中的初步有效性。
[Translation] Main objectives: Stage I: to evaluate the safety and tolerability of single administration of SYH9016 injection; Stage II: to evaluate the safety and tolerability of multiple administrations of SYH9016 injection; to determine the recommended dose of SYH9016 injection. Secondary objectives: Stage I: To compare the pharmacokinetic characteristics of each dose group of SYH9016 injection and single administration of leuprorelin acetate microsphere injection in patients with prostate cancer suitable for endocrine therapy; to compare the pharmacodynamic characteristics of each dose group of SYH9016 injection and single administration of leuprorelin acetate microsphere injection in patients with prostate cancer suitable for endocrine therapy; Stage II: To compare the pharmacokinetic characteristics of multiple administrations of SYH9016 injection and leuprorelin acetate microsphere injection in patients with prostate cancer suitable for endocrine therapy; to compare the pharmacodynamic characteristics of multiple administrations of SYH9016 injection and leuprorelin acetate microsphere injection in patients with prostate cancer suitable for endocrine therapy; to evaluate the preliminary efficacy of SYH9016 injection in patients with prostate cancer suitable for endocrine therapy.