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Clinical Trials associated with JMKX-001899 / Not yet recruitingPhase 1 A Phase Ib, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of JMKX001899 in Combination With Other Therapies in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With KRAS G12C Mutation.
This is a phase 1b, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of JMKX001899 in combination with IN10018 or in combination with chemotherapy or in combination with IN10018 and chemotherapy in subjects with locally advanced or metastatic NSCLC with KRAS G12C mutation.
/ Not yet recruitingPhase 1 A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Effect of JMKX001899 on the QTc Interval in Healthy Subjects
Study to assess the effect of JMKX001899 on QTc interval in healthy volunteers
[14C]JMKX001899在中国健康受试者中的物质平衡研究
[Translation] [14C] JMKX001899: A material balance study in Chinese healthy subjects
主要目的
1) 定量分析男性健康受试者单次口服[14C]JMKX001899后排泄物中的总放射性,获得人体放射性总回收率和主要排泄途径;
2) 定量分析男性健康受试者单次口服[14C]JMKX001899后全血和血浆中的总放射性,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) 定量分析男性健康受试者单次口服[14C]JMKX001899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JMKX001899在人体内的代谢途径及消除途径。
次要目的
1) 采用已验证的LC-MS/MS方法定量分析血浆中JMKX001899和代谢产物M8或其他代谢产物(如适用)的浓度,获得血浆中JMKX001899和代谢产物M8或其他代谢产物(如适用)的药代动力学参数。
2)获得全血总放射性的药代动力学参数(如适用)。
3) 观察男性健康受试者单次口服[14C]JMKX001899后的安全性。
[Translation] Main purpose
1) To quantitatively analyze the total radioactivity in the excreta of male healthy subjects after a single oral administration of [14C]JMKX001899, and obtain the total recovery rate of human radioactivity and the main excretion pathway;
2) To quantitatively analyze the total radioactivity in whole blood and plasma of male healthy subjects after a single oral administration of [14C]JMKX001899, obtain the pharmacokinetic parameters of total radioactivity in 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]JMKX001899, identify the main metabolites, and determine the metabolic pathways and elimination pathways of JMKX001899 in the human body.
Secondary purpose
1) To quantitatively analyze the concentrations of JMKX001899 and metabolite M8 or other metabolites (if applicable) in plasma using a validated LC-MS/MS method, and obtain the pharmacokinetic parameters of JMKX001899 and metabolite M8 or other metabolites (if applicable) in plasma.
2) Obtain pharmacokinetic parameters of total radioactivity in whole blood (if applicable).
3) Observe the safety of [14C]JMKX001899 after a single oral administration in healthy male subjects.
100 Clinical Results associated with JMKX-001899
100 Translational Medicine associated with JMKX-001899
100 Patents (Medical) associated with JMKX-001899
100 Deals associated with JMKX-001899