[Translation] A dose-escalation tolerability, pharmacokinetics, safety, and efficacy study of ZG5266 tablets was conducted in healthy subjects and PBC patients.
健 康 受 试 者 中 单 次 给 药 剂 量 递 增 ( SAD ) 和 多 次 给 药 剂 量 递 增(MAD)部分(Ⅰ期)。
主要目的:考察不同剂量ZG5266片在健康受试者中单次给药和多次给药的耐受性和安全性。
次要目的:考察 ZG5266 片在健康受试者中单次给药和多次给药的药代动力学特征。
在PBC患者中多次给药的有效性、安全性和药代动力学部分(II期)。
主要目的:考察ZG5266片选定剂量联合UDCA在对UDCA应答不佳或ZG5266片单药治疗在对UDCA不耐受的PBC患者中的有效性。
次要目的:考察ZG5266片选定剂量联合UDCA在对UDCA应答不佳或ZG5266片单药治疗在对UDCA不耐受的PBC患者中的安全性;考察ZG5266片在PBC患者中多次给药的药代动力学特征。
[Translation] Single ascending dose (SAD) and multiple ascending dose (MAD) parts in healthy subjects (Phase I).
Primary objective: To investigate the tolerability and safety of single and multiple administrations of different doses of ZG5266 tablets in healthy subjects.
Secondary objective: To investigate the pharmacokinetic characteristics of single and multiple administrations of ZG5266 tablets in healthy subjects.
Efficacy, safety and pharmacokinetics of multiple administrations in PBC patients (Phase II).
Primary objective: To investigate the efficacy of selected doses of ZG5266 tablets combined with UDCA in PBC patients who have a poor response to UDCA or ZG5266 tablets monotherapy in UDCA-intolerant patients.
Secondary objectives: To investigate the safety of selected doses of ZG5266 tablets combined with UDCA in PBC patients with poor response to UDCA or ZG5266 tablets alone in UDCA intolerance; to investigate the pharmacokinetic characteristics of ZG5266 tablets after multiple doses in PBC patients.