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MechanismHBV capsid inhibitors |
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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
评价VD1219在健康受试者和慢性乙型肝炎患者中随机、单次和多次口服给药的耐受性、药代动力学特征以及初步评价其抗病毒活性的I期临床试验
[Translation] A phase I clinical trial to evaluate the tolerability, pharmacokinetic characteristics and preliminary antiviral activity of VD1219 in healthy subjects and patients with chronic hepatitis B after randomized, single and multiple oral administrations
主要目的:评价VD1219在中国健康成年受试者中单次和多次口服给药后的安全性和耐受性以及对中国慢性乙型肝炎患者中的安全性和耐受性。
次要目的:1)评估VD1219及其主要代谢产物(如适用)健康成年受试者单次和多次口服给药后的药代动力学(PK)特征;2)评估VD1219在中国慢性乙型肝炎患者给药后的药代动力学(PK)特征;3)评估VD1219在中国慢性乙型肝炎患者给药后的初步有效性。
[Translation] Primary objective: To evaluate the safety and tolerability of VD1219 after single and multiple oral administration in healthy adult subjects in China and in Chinese patients with chronic hepatitis B.
Secondary objectives: 1) To evaluate the pharmacokinetic (PK) characteristics of VD1219 and its major metabolites (if applicable) after single and multiple oral administration in healthy adult subjects; 2) To evaluate the pharmacokinetic (PK) characteristics of VD1219 after administration in Chinese patients with chronic hepatitis B; 3) To evaluate the preliminary efficacy of VD1219 after administration in Chinese patients with chronic hepatitis B.
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