8
Clinical Trials associated with HSK-44459 / Not yet recruitingPhase 2 A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK44459 in Subjects With Moderate to Severe Plaque Psoriasis
The purpose of this study is to assess the efficacy and safety of HSK44459 administered orally for moderate to severe plaque psoriasis in adults.
[14C]HSK44459在中国成年男性健康参与者体内的物质平衡研究
[Translation] Study on the balance of [14C]HSK44459 in healthy Chinese adult male participants
主要目的:
1. 定量分析参与者口服[14C]HSK44459 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. 定量分析参与者单次口服[14C]HSK44459 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. 考察参与者口服[14C]HSK44459 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 HSK44459、代谢产物 HSK46213 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 HSK44459、代谢产物 HSK46213 及其他代谢产物(如适用)的药代动力学参数; 2. 观察[14C]HSK44459 单次给药后参与者的安全性。
[Translation] Primary Objectives:
1. To quantitatively analyze the total radioactivity excreted in participants after oral administration of [14C]HSK44459, and to determine the recovery rate and primary excretion pathway of radioactivity in humans; 2. To quantitatively analyze the total radioactivity in whole blood and plasma after a single oral administration of [14C]HSK44459, to determine the pharmacokinetic parameters of total radioactivity in plasma and whole blood (if applicable), and to investigate the distribution of total radioactivity between whole blood and plasma; 3. To investigate the radioactive metabolite profiles in plasma, urine, and feces of participants after oral administration of [14C]HSK44459, to identify the primary metabolites, and to determine the metabolic and elimination pathways. Secondary objectives:
1. To quantitatively analyze the plasma concentrations of parent drug HSK44459, its metabolite HSK46213, and other metabolites (if applicable) using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, and to evaluate the pharmacokinetic parameters of parent drug HSK44459, its metabolite HSK46213, and other metabolites (if applicable) in plasma;
2. To observe the safety of participants after a single dose of [14C]HSK44459.
/ Not yet recruitingPhase 2 A Multicenter, Open-label Study to Evaluate the Long-term Safety and Efficacy of HSK44459 Tablets for the Treatment of Patients With Bechet's Disease
This is a long-term extension study of HSK44459-202 in eligible participants who have completed the Week 12 visit of the originating Study HSK44459-202. The total duration of this study will be up to 56 weeks which will include a 52-week treatment period, and a 4-week safety follow-up period after the last study intervention administration. Safety will be assessed by the incidence and severity of adverse events during the study.
100 Clinical Results associated with HSK-44459
100 Translational Medicine associated with HSK-44459
100 Patents (Medical) associated with HSK-44459
100 Deals associated with HSK-44459