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Clinical Trials associated with HRS-5965A Multicenter, Randomized, Open-label, Active-comparator Controlled Phase III Study to Evaluate the Efficacy and Safety of HRS-5965 Capsule in Patients With Paroxysmal Nocturnal Hemoglobinuria
A study of the efficacy and safety of HRS-5965 capsules compared to eculizumab for 24 weeks in patients with PNH.
[14C]HRS-5965 在中国成年健康男性受试者体内的物质平衡临床研究
[Translation] Clinical study on the material balance of [14C]HRS-5965 in healthy adult male subjects in China
主要研究目的 :
1.定量分析健康受试者单次口服[14C] HRS-5965 后,排泄物中的总放射量,获得人体放射性的回收率数据和主要排泄途径;
2.定量分析健康受试者单次口服[14C] HRS-5965 后全血和血浆中的总放射量,获得血浆总放射性的药代动力学参数,并考察全血和血浆中总放射性的分配情况;
3.定量分析健康受试者单次口服[14C] HRS-5965 后血浆、尿液和粪便的放射性代谢物谱,鉴定主要代谢产物,确定 HRS-5965在人体内的代谢途径及消除途径。
[Translation] Main research objectives:
1. Quantitatively analyze the total radioactivity in excreta after a single oral administration of [14C] HRS-5965 to healthy subjects, and obtain the recovery rate data and main excretion pathways of human radioactivity;
2. Quantitatively analyze the total radioactivity in whole blood and plasma after a single oral administration of [14C] HRS-5965 to healthy subjects, obtain the pharmacokinetic parameters of total plasma radioactivity, and investigate the distribution of total radioactivity in whole blood and plasma;
3. Quantitatively analyze the radioactive metabolite spectrum of plasma, urine and feces of healthy subjects after a single oral administration of [14C] HRS-5965, identify the main metabolites, and determine the metabolic pathways and elimination pathways of HRS-5965 in the human body.
Phase I Clinical Trial of Mass Balance of [14C] HRS-5965 in Healthy Chinese Subjects
Evaluate the Mass Balance of [14C] HRS-5965 in Healthy Adult Volunteers.
100 Clinical Results associated with HRS-5965
100 Translational Medicine associated with HRS-5965
100 Patents (Medical) associated with HRS-5965
100 Deals associated with HRS-5965