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MechanismMitophagy inducers |
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Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
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Inactive Indication- |
Drug Highest PhasePreclinical |
First Approval Ctry. / Loc.- |
First Approval Date- |
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Inactive Indication- |
Drug Highest PhaseDiscovery |
First Approval Ctry. / Loc.- |
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/ Active, not recruitingPhase 1 Mass Balance Study of [14C] TJ0113 in Healthy Chinese Subjects
Mass Balance Study of [14C] TJ0113 in Healthy Chinese Subjects
[14C]TJ0113在中国健康受试者中的物质平衡研究
[Translation] [14C]TJ0113 Material balance study 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]TJ0113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]TJ0113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]TJ0113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TJ0113在人体内的代谢及消除途径。
次要研究目的:
1)采用经验证的LC-MS/MS方法定量分析血浆中TJ0113及其代谢产物(如适用)的浓度,获得血浆中TJ0113及其代谢产物(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]TJ0113后的安全性。
[Translation] Main research objectives:
1) Quantitative analysis of the total radioactivity in excreta after a single oral administration of [14C]TJ0113 in healthy male subjects, to obtain the total recovery rate of human radioactivity, excretion data and main excretion pathways;
2) Quantitative analysis of the total radioactivity in whole blood and plasma after a single oral administration of [14C]TJ0113 in healthy male subjects, to obtain the pharmacokinetic parameters of total radioactivity in whole blood (if applicable) and plasma, and to investigate the distribution of total radioactivity in whole blood and plasma;
3) Quantitative analysis of the radioactive metabolite profiles in human plasma, urine and feces after a single oral administration of [14C]TJ0113 in healthy male subjects, to identify the main metabolites, and to determine the metabolism and elimination pathways of TJ0113 in the human body.
Secondary study objectives:
1) To quantitatively analyze the concentration of TJ0113 and its metabolites (if applicable) in plasma using a validated LC-MS/MS method and obtain the pharmacokinetic parameters of TJ0113 and its metabolites (if applicable) in plasma;
2) To observe the safety of [14C]TJ0113 after a single oral administration in healthy male subjects.
A Randomized, Double-blind, Placebo Parallel-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TJ0113 Capsule in Patients with Early-stage Parkinson's Disease
A randomized, double-blind, placebo parallel-controlled Phase II clinical trial to evaluate the efficacy and safety of TJ0113 capsule in patients with early-stage Parkinson's disease
100 Clinical Results associated with Hangzhou Tianji Jishi Biotechnology Co., Ltd.
0 Patents (Medical) associated with Hangzhou Tianji Jishi Biotechnology Co., Ltd.
100 Deals associated with Hangzhou Tianji Jishi Biotechnology Co., Ltd.
100 Translational Medicine associated with Hangzhou Tianji Jishi Biotechnology Co., Ltd.