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Clinical Trials associated with HSK-39297A Multicenter, Open-label Study to Evaluate the Long-term Safety, Tolerability and Efficacy of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria(PNH)
This is a multicenter, open-label study to evaluate the long-term safety, tolerability and efficacy of HSK39297. Adult patients with PNH who had previously received and completed HSK39297 study treatment will be included. Eligible subjects can maintain HSK39297 treatment until the end of the study.
A Randomized, Double-blind, and Placebo-controlled Parallel Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK39297 Tablets in Treatment of Patients with Primary IgAN
Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN
[14C]HSK39297在中国成年男性健康受试者体内的物质平衡研究
[Translation] Study on the material balance of [14C]HSK39297 in healthy adult male subjects in China
主要研究目的
1、定量分析健康受试者口服[14C]HSK39297后排泄物中的总放射性,获得人体放射性回收率和主要排泄途径;
2、定量分析受试者单次口服[14C]HSK39297后全血和血浆中的总放射性,获得血浆及全血(如适用)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、考察受试者口服[14C]HSK39297后血浆、尿液和粪便的放射性代谢物谱,鉴定主要代谢产物,确定代谢途径及消除途径。
次要研究目的
1、采用已验证的液相色谱串联质谱联用法(LC-MS/MS)定量分析血浆中原形药HSK39297及其他代谢产物(如适用)的血药浓度,进而评价血浆中原形药HSK39297及其他代谢产物(如适用)的药代动力学参数;
2、观察[14C]HSK39297单次给药后受试者的安全性。
[Translation] Main research objectives
1. Quantitatively analyze the total radioactivity in the excreta of healthy subjects after oral administration of [14C]HSK39297, and obtain the human radioactivity recovery rate and main excretion pathway;
2. Quantitatively analyze the total radioactivity in whole blood and plasma of subjects after a single oral administration of [14C]HSK39297, obtain the pharmacokinetic parameters of total radioactivity in plasma and whole blood (if applicable), and investigate the distribution of total radioactivity in whole blood and plasma;
3. Investigate the radioactive metabolite spectrum of plasma, urine and feces of subjects after oral administration of [14C]HSK39297, identify the main metabolites, and determine the metabolic pathways and elimination pathways.
Secondary study objectives
1. To quantitatively analyze the plasma concentration of parent drug HSK39297 and other metabolites (if applicable) by using the validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method, and then evaluate the pharmacokinetic parameters of parent drug HSK39297 and other metabolites (if applicable) in plasma;
2. To observe the safety of subjects after a single dose of [14C]HSK39297.
100 Clinical Results associated with HSK-39297
100 Translational Medicine associated with HSK-39297
100 Patents (Medical) associated with HSK-39297
100 Deals associated with HSK-39297