[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the safety and efficacy of RP901 tablets in the treatment of knee osteoarthritis
主要目的:评价RP901片对于缓解膝骨关节炎疼痛、维持或再生膝关节软骨组织的有效性。
次要目的:评价RP901片对于膝骨关节炎患者的临床安全性。
探索性目的:探索观察服用RP901片后骨密度(BMD)、骨和软骨代谢指标及生物标志物的变化;探索不同给药剂量下RP901药代动力学特征。
[Translation] Primary objective: To evaluate the effectiveness of RP901 tablets in relieving knee osteoarthritis pain and maintaining or regenerating knee cartilage tissue.
Secondary objective: To evaluate the clinical safety of RP901 tablets in patients with knee osteoarthritis.
Exploratory objective: To explore and observe the changes in bone mineral density (BMD), bone and cartilage metabolism indicators and biomarkers after taking RP901 tablets; to explore the pharmacokinetic characteristics of RP901 at different dosages.