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MechanismHBV core protein inhibitors |
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Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
在健康者中评价ABI-H2158的安全性、耐受性;和在慢性乙肝感染患者中评价ABI-H2158药代动力学和药效学的研究
[Translation] A study to evaluate the safety and tolerability of ABI-H2158 in healthy subjects and the pharmacokinetics and pharmacodynamics of ABI-H2158 in patients with chronic hepatitis B infection
主要目的: 在慢性HBV(CHB)感染患者中(第3部分)评价ABI-H2158口服给药的剂量相关安全性和耐受性;在ABI-H2158给药患者中(第3部分)评价HBV DNA病毒负荷的变化 次要目的: 单次和14天多次给药后,在CHB患者中评价ABI-H2158及其代谢物的血浆PK(第3部分)
[Translation] Primary Objectives: To evaluate the dose-related safety and tolerability of oral ABI-H2158 in patients with chronic HBV (CHB) infection (Part 3); To evaluate changes in HBV DNA viral load in patients treated with ABI-H2158 (Part 3) Secondary Objectives: To evaluate the plasma PK of ABI-H2158 and its metabolites in CHB patients after single and multiple doses over 14 days (Part 3)
一项评价含ABI-H2158方案治疗慢性乙型肝炎感染的多中心、单盲、安慰剂对照、多队列的2a期研究
[Translation] A multicenter, single-blind, placebo-controlled, multi-cohort phase 2a study evaluating an ABI-H2158-containing regimen for the treatment of chronic hepatitis B infection
在CHB受试者中评价ABI-H2158 + ETV联合治疗的安全性和耐受性; 在CHB受试者中评价ABI-H2158在降低HBV DNA方面的作用
[Translation] To evaluate the safety and tolerability of ABI-H2158 + ETV combination therapy in CHB subjects; To evaluate the effect of ABI-H2158 in reducing HBV DNA in CHB subjects
一项在慢性乙型肝炎患者中评估含 ABI-H0731方案的随机、IIa期、多中心、开放性研究
[Translation] A randomized, phase IIa, multicenter, open-label study evaluating an ABI-H0731-containing regimen in patients with chronic hepatitis B
主要目的 评估731联用ETV±Peg-IFNα治疗CHB受试者时的安全性和耐受性 次要目的 评估731联用ETV±Peg-IFNα降低CHB受试者HBV pgRNA水平的作用 评估731联用ETV±Peg-IFNα降低CHB受试者HBV DNA水平的作用 评估731联用ETV±Peg-IFNα降低CHB受试者HBV抗原(即HBeAg、HBcrAg和HBsAg)的作用 评估731联用ETV±Peg-IFNα对使丙氨酸氨基转移酶(ALT)恢复正常的作用 在CHB受试者中评估731的PK以及在未来评估Peg-IFNα和ETV的PK 评估731联用ETV±Peg-IFNα时耐药性的形成情况
[Translation] Primary Objective To evaluate the safety and tolerability of 731 combined with ETV±Peg-IFNα in the treatment of CHB subjects Secondary Objectives To evaluate the effect of 731 combined with ETV±Peg-IFNα in reducing HBV pgRNA levels in CHB subjects To evaluate the effect of 731 combined with ETV±Peg-IFNα in reducing HBV DNA levels in CHB subjects To evaluate the effect of 731 combined with ETV±Peg-IFNα in reducing HBV antigens (i.e., HBeAg, HBcrAg, and HBsAg) in CHB subjects To evaluate the effect of 731 combined with ETV±Peg-IFNα in restoring alanine aminotransferase (ALT) to normal To evaluate the PK of 731 in CHB subjects and the PK of Peg-IFNα and ETV in the future To evaluate the development of drug resistance when 731 is combined with ETV±Peg-IFNα
100 Clinical Results associated with Ashan Berry Biotechnology (Shanghai) Co., Ltd.
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100 Translational Medicine associated with Ashan Berry Biotechnology (Shanghai) Co., Ltd.