[Translation] A single-center, randomized, double-blind, multiple-dose, dose-escalation, placebo-controlled Phase Ib/IIa clinical trial to evaluate the safety, tolerability, pharmacokinetics, and early pharmacodynamics of BGT-002 tablets in NASH subjects
主要目的:评价 NASH 受试者口服 BGT-002 片后的安全性、耐受性
次要目的:1) 评估 NASH 受试者口服 BGT-002 片后的药代动力学特征;2) 评估 BGT-002 对 NASH 受试者脂代谢的作用;3) 评估 BGT-002 对 NASH 受试者肝脏功能相关生化指标的作用。
探索性目的:评估 BGT-002 在 NASH 受试者体内的生物标志物特征。
[Translation] Primary purpose: To evaluate the safety and tolerability of BGT-002 tablets after oral administration in NASH subjects
Secondary purpose: 1) To evaluate the pharmacokinetic characteristics of BGT-002 tablets after oral administration in NASH subjects; 2) To evaluate the effect of BGT-002 on lipid metabolism in NASH subjects; 3) To evaluate the effect of BGT-002 on biochemical indices related to liver function in NASH subjects.
Exploratory purpose: To evaluate the biomarker characteristics of BGT-002 in NASH subjects.