[Translation] A multicenter, randomized, placebo-controlled phase IIa clinical trial evaluating the safety, tolerability, preliminary efficacy, and pharmacokinetic characteristics of RJ4287 tablets in adult patients with metabolic-associated steatohepatitis (MASH).
主要目的:评估RJ4287片在代谢相关脂肪性肝炎患者中的安全性和耐受性;
次要目的:评估RJ4287片在代谢相关脂肪性肝炎患者中的初步有效性;评估RJ4287片在代谢相关脂肪性肝炎患者体内的药代动力学特征。
探索性目的:探索RJ4287片对性激素结合球蛋白(SHBG)水平的影响。探索RJ4287片对N末端III型胶原前肽(PRO-C3)、高尔基蛋白73(GP73)、CK-18 M30和/或M65、透明质酸(HA)、基质金属蛋白酶抑制剂-1(TIMP-1)和Ⅲ型前胶原氨基端肽(PIIINP)水平的影响。
[Translation] Primary Objective: To evaluate the safety and tolerability of RJ4287 tablets in patients with metabolic-associated steatohepatitis (MAS).
Secondary Objectives: To evaluate the preliminary efficacy of RJ4287 tablets in patients with MAS; to evaluate the pharmacokinetic characteristics of RJ4287 tablets in patients with MAS.
Exploratory Objectives: To investigate the effect of RJ4287 tablets on sex hormone-binding globulin (SHBG) levels. To investigate the effects of RJ4287 tablets on the levels of N-terminal type III collagen propeptide (PRO-C3), Golgi protein 73 (GP73), CK-18 M30 and/or M65, hyaluronic acid (HA), matrix metalloproteinase inhibitor-1 (TIMP-1), and type III procollagen N-terminal peptide (PIIINP).