[Translation] A randomized, open-label, active-drug parallel-controlled, multi-dose phase Ib clinical trial evaluating the safety, tolerability, pharmacokinetics, and anti-HBV activity of NCO-48F capsules in chronic hepatitis B-naïve patients
主要目的:评估NCO-48F在慢性乙型肝炎初治患者中连续给药28天的抗乙肝病毒活性作用。
次要目的:
(1)评估NCO-48F多次口服给药的安全性和耐受性。
(2)评估NCO-48F单次、多次口服给药的药代动力学特征。
(3)初步探索NCO-48F多次口服给药治疗慢性乙型肝炎的II期临床推荐剂量。
[Translation] Main objective: To evaluate the anti-HBV activity of NCO-48F in chronic hepatitis B-naïve patients administered continuously for 28 days.
Secondary purpose:
(1) To evaluate the safety and tolerability of multiple oral administration of NCO-48F.
(2) To evaluate the pharmacokinetic characteristics of single and multiple oral administration of NCO-48F.
(3) Preliminary exploration of the recommended dose of NCO-48F for the treatment of chronic hepatitis B by multiple oral administration.