8
Clinical Trials associated with CMS-D001 / Not yet recruitingPhase 2 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of CMS-D001 in Adult Patients With Moderate to Severe Atopic Dermatitis
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial, aiming to evaluate the efficacy, safety, and tolerability of CMS-D001 in participants with moderate to severe atopic dermatitis, as well as to assess the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of CMS-D001 and its major metabolites (as applicable) in participants with moderate to severe atopic dermatitis, so as to provide a basis for the dosage of the Phase III confirmatory clinical trial.
/ Not yet recruitingPhase 2/3 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅱ/Ⅲ Clinical Study to Evaluate the Efficacy and Safety of CMS-D001 Tablets in Adult Patients With Moderate to Severe Plaque Psoriasis
This study adopted a multicenter, randomized, double-blind, placebo-controlled phase II/III operation seamless adaptive design, aiming to evaluate the efficacy, safety and tolerability of CMS-D001 tablets in the treatment of patients with moderate to severe plaque psoriasis. The trial consists of two parts, including the Phase II clinical research stage and the Phase III clinical research stage.
[14C] CMS-D001在中国健康成年男性参与者中的物质平衡研究
[Translation] [14C] CMS-D001 Material Balance Study in Healthy Adult Male Participants in China
主要目的:
1.定量分析健康男性参与者口服[14C] CMS-D001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.考察健康男性参与者口服[14C] CMS-D001后全血与血浆总放射性的分配比,以及全血(如适用)和血浆中总放射性的药代动力学特征;
3.获得健康男性参与者口服[14C] CMS-D001后血浆、尿液和粪便的放射性代谢物谱,鉴定主要代谢产物,确定主要生物转化途径。
次要目的:
1.采用已验证的LC-MS/MS方法定量分析血浆中CMS-D001、代谢物M414-2及其它主要代谢产物(如适用)的浓度,获得血浆中CMS-D001、M414-2及其它主要代谢产物(如适用)的药代动力学参数;
2.观察中国健康成年男性参与者单次口服[14C] CMS-D001后的安全性。
[Translation] Main objectives:
1. To quantitatively analyze the total radioactivity in the excrement of healthy male participants after oral administration of [14C] CMS-D001, and to obtain the human radioactivity recovery rate and main excretion pathway;
2. To investigate the partition ratio of total radioactivity in whole blood and plasma after oral administration of [14C] CMS-D001 in healthy male participants, and the pharmacokinetic characteristics of total radioactivity in whole blood (if applicable) and plasma;
3. To obtain the radiometabolite profiles of plasma, urine, and feces after oral administration of [14C] CMS-D001 in healthy male participants, identify the major metabolites, and determine the main biotransformation pathways. Secondary objectives: 1. To quantitatively analyze the plasma concentrations of CMS-D001, metabolite M414-2, and other major metabolites (if applicable) using a validated LC-MS/MS method, and to obtain the pharmacokinetic parameters of CMS-D001, M414-2, and other major metabolites (if applicable) in plasma;
2. To observe the safety of a single oral administration of [14C] CMS-D001 to healthy adult male participants in China.
100 Clinical Results associated with CMS-D001
100 Translational Medicine associated with CMS-D001
100 Patents (Medical) associated with CMS-D001
100 Deals associated with CMS-D001