[Translation] Phase Ib clinical trial to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetic characteristics of MBT-1316 tablets in patients with chronic hepatitis B after single and multiple doses
主要目的:评价MBT-1316 片在慢性乙型肝炎患者中单次给药的安全性和耐受性;评价MBT-1316 片在慢性乙型肝炎患者中多次给药的安全性和耐受性。
次要目的:评价MBT-1316 片在慢性乙型肝炎患者中多次给药的药效学特征;评价MBT-1316 片在慢性乙型肝炎患者中单次给药的药代动力学特征;评价MBT-1316 片在慢性乙型肝炎患者中多次给药的药代动力学特征。
[Translation] Primary objective: To evaluate the safety and tolerability of MBT-1316 tablets after single administration in patients with chronic hepatitis B; To evaluate the safety and tolerability of MBT-1316 tablets after multiple administration in patients with chronic hepatitis B.
Secondary objective: To evaluate the pharmacodynamic characteristics of MBT-1316 tablets after multiple administration in patients with chronic hepatitis B; To evaluate the pharmacokinetic characteristics of MBT-1316 tablets after single administration in patients with chronic hepatitis B; To evaluate the pharmacokinetic characteristics of MBT-1316 tablets after multiple administration in patients with chronic hepatitis B.