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Drug Highest PhasePhase 2 |
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MechanismHBV capsid inhibitors |
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Inactive Indication- |
Drug Highest PhasePhase 2 |
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Inactive Indication- |
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Phase Ib/II Study of LW231 in Patients With Chronic Hepatitis B: Evaluation of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy With Multiple-Dose, Dose-Escalation, and Combination With Nucleos(t)Ide Analogs (NUC)
This is a Phase Ib/II, multicenter, randomized, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of LW231 in participants with chronic hepatitis B virus (HBV) infection. The trial will include multiple-dose regimens of LW231 and assess LW231 in combination with NUCs.
[14C]LW402在中国健康受试者中的物质平衡研究
[Translation] [14C] A material balance study of LW402 in Chinese healthy subjects
主要研究目的:
1) 定量分析男性健康受试者单次口服[14C]LW402后排泄物中的总放射性,获得人体放射性总回收率、排泄数据和主要排泄途径;
2) 定量分析男性健康受试者单次口服[14C]LW402后全血和血浆中的总放射性,获得全血(如适用)和血浆总放射性的药代动力学参数,考察全血和血浆中总放射性的分配情况;
3) 定量分析男性健康受试者单次口服[14C]LW402后人血浆、尿液和粪便的放射性代谢物谱,鉴定主要代谢产物,确定LW402在人体内的代谢途径及消除途径。
次要研究目的:
1) 采用经验证的液相色谱串联质谱法(LC-MS/MS)定量分析血浆中LW402及其代谢产物LW40241和其他代谢产物(如适用)的浓度,获得血浆中LW402及其代谢产物LW40241和其他代谢产物(如适用)的药代动力学参数;
2) 观察男性健康受试者单次口服[14C]LW402后的安全性。
[Translation] Main research objectives:
1) To quantitatively analyze the total radioactivity in the excreta of male healthy subjects after a single oral administration of [14C]LW402, and obtain the total recovery rate of human radioactivity, excretion data and main excretion pathways;
2) To quantitatively analyze the total radioactivity in whole blood and plasma of male healthy subjects after a single oral administration of [14C]LW402, obtain the pharmacokinetic parameters of total radioactivity in whole blood (if applicable) and plasma, and investigate the distribution of total radioactivity in whole blood and plasma;
3) To quantitatively analyze the radioactive metabolite profiles in human plasma, urine and feces of male healthy subjects after a single oral administration of [14C]LW402, identify the main metabolites, and determine the metabolic pathways and elimination pathways of LW402 in the human body.
Secondary study objectives:
1) To quantitatively analyze the concentrations of LW402 and its metabolite LW40241 and other metabolites (if applicable) in plasma using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method, and to obtain the pharmacokinetic parameters of LW402 and its metabolite LW40241 and other metabolites (if applicable) in plasma;
2) To observe the safety of [14C]LW402 after a single oral administration in healthy male subjects.
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of LW402 in Patients With Moderate-to-Severe Atopic Dermatitis
This is a multi-center, randomized, double blind, placebo-controlled phase 2 study to evaluate the efficacy, safety, PK and PD ofLW402 in patients with moderate-to-severe atopic dermatitis.
100 Clinical Results associated with Shanghai Changsen Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Shanghai Changsen Pharmaceutical Co., Ltd.
100 Deals associated with Shanghai Changsen Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Shanghai Changsen Pharmaceutical Co., Ltd.