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Inactive Indication- |
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
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MechanismLRRK2 inhibitors |
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Inactive Indication- |
Drug Highest PhasePreclinical |
First Approval Ctry. / Loc.- |
First Approval Date- |
[14C]SY-009在男性成年健康受试者体内的物质平衡研究
[Translation] [14C]SY-009 Material Balance Study in Male Adult Healthy Subjects
主要目的:
1.定量分析受试者口服[14C] SY-009后排泄物中的总放射性,获得人体放射性排泄率数据和主要排泄途径;
2.定量分析受试者单次口服[14C]SY-009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.获得受试者口服[14C]SY-009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LC-MS/MS方法定量分析血浆中SY-009及其代谢产物(如适用)的浓度,获得血浆中SY-009及其代谢产物(如适用)的药代动力学参数;
2.观察[14C]SY-009单次给药后受试者的安全性。
[Translation] main purpose:
1. Quantitatively analyze the total radioactivity in the excreta of subjects after oral administration of [14C] SY-009, and obtain the data of human radioactive excretion rate and the main excretion route;
2. Quantitatively analyze the total radioactivity in whole blood and plasma after a single oral administration of [14C]SY-009, obtain the pharmacokinetic parameters of total radioactivity in plasma, and investigate the distribution of total radioactivity in whole blood and plasma;
3. Obtain the spectrum of radioactive metabolites in plasma, urine and feces after oral administration of [14C]SY-009, identify the main metabolites, and determine the metabolic pathway and elimination pathway.
Secondary purpose:
1. Use the validated LC-MS/MS method to quantitatively analyze the concentration of SY-009 and its metabolites (if applicable) in plasma, and obtain the pharmacokinetic parameters of SY-009 and its metabolites (if applicable) in plasma ;
2. Observe the safety of subjects after a single administration of [14C]SY-009.
Phase Ib Clinical Study to Evaluate Safety, Tolerance,Pharmacokinetics and Efficacy of SY-007 After Intravenous Injection in Acute Ischemic Stroke Subjects
This Phase 1b multiple center, randomized, double-blind, placebo-controlled study is a dose escalation trial evaluating the safety, tolerability, PK characteristics and efficacy of SY-007 after injection in acute ischemicstroke patients. The immunogenicity of SY-007 will be evaluated and this study will provide the recommended dosage for subsequent clinical trials.
一项多中心、随机、双盲、安慰剂对照的Ⅱ期试验以评估口服不同剂量SY-009胶囊治疗T2DM患者12周的有效性和安全性
[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II trial to evaluate the 12-week efficacy and safety of different oral doses of SY-009 capsules in patients with T2DM
主要目的:
评估2型糖尿病患者口服不同剂量SY-009胶囊治疗12周时HbA1c较基线的变化。
次要目的:
1)评估2型糖尿病患者口服不同剂量SY-009胶囊治疗12周的安全性和耐受性;
2)评估2型糖尿病患者口服不同剂量SY-009胶囊对血糖(空腹血糖、餐后血糖、自测血糖)、胰岛功能、GLP-1/GIP的影响;
3) 评估2型糖尿病患者口服不同剂量SY-009胶囊血药浓度水平。
探索性目的:
1)评估2型糖尿病患者口服不同剂量SY-009胶囊对12周末体重较基线的变化;
2)评估2型糖尿病患者口服不同剂量SY-009胶囊对每周自发排便次数较基线的变化;
评估2型糖尿病患者口服不同剂量SY-009胶囊治疗12周时血脂较基线的变化。
[Translation] main purpose:
To evaluate changes from baseline in HbA1c in patients with type 2 diabetes treated with different doses of SY-009 capsules for 12 weeks.
Secondary purpose:
1) To evaluate the safety and tolerability of different doses of SY-009 capsules orally in patients with type 2 diabetes for 12 weeks;
2) To evaluate the effects of oral administration of different doses of SY-009 capsules on blood glucose (fasting blood glucose, postprandial blood glucose, self-measured blood glucose), pancreatic islet function, and GLP-1/GIP in patients with type 2 diabetes;
3) To evaluate the blood concentration of SY-009 capsules in different doses of oral administration in patients with type 2 diabetes.
Exploratory Purpose:
1) To evaluate the change of body weight at the end of 12 weeks in patients with type 2 diabetes mellitus orally with different doses of SY-009 capsules from baseline;
2) To evaluate the changes in the number of spontaneous bowel movements per week compared with baseline in patients with type 2 diabetes orally taking different doses of SY-009 capsules;
To evaluate changes in blood lipids from baseline in patients with type 2 diabetes treated with different doses of SY-009 capsules for 12 weeks.
100 Clinical Results associated with Suzhou Yabao Pharmaceutical R&D Co., Ltd.
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100 Translational Medicine associated with Suzhou Yabao Pharmaceutical R&D Co., Ltd.