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Inactive Indication- |
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ Active, not recruitingPhase 1 [14C] ICP-332在中国健康成年男性受试者中的物质平衡和生物转化研究
[Translation] Study on the material balance and biotransformation of [14C]ICP-332 in healthy Chinese adult male subjects
1. 定量分析健康受试者单次口服[14C]ICP-332后,排泄物中的总放射性,获得人体放射性排泄率数据,并对主要排泄途径进行研究。
2. 定量分析健康受试者单次口服[14C]ICP-332后全血(如适用)和血浆中的总放射性。获得血浆和全血(如适用)中总放射性的药代动力学(PK)参数,并考察全血和血浆中总放射性的分配情况(如适用)。
3. 获得健康受试者单次口服[14C]ICP-332后,血浆、尿液、粪便中的代谢物谱,鉴定主要代谢产物,确定ICP-332在人体内的代谢途径和消除径。
[Translation] 1. Quantitatively analyze the total radioactivity in excreta after a single oral administration of [14C]ICP-332 to healthy subjects, obtain data on human radioactive excretion rate, and study the main excretion pathways.
2. Quantitatively analyze the total radioactivity in whole blood (if applicable) and plasma after a single oral administration of [14C]ICP-332 to healthy subjects. Obtain the pharmacokinetic (PK) parameters of total radioactivity in plasma and whole blood (if applicable), and investigate the distribution of total radioactivity in whole blood and plasma (if applicable).
3. Obtain the metabolite profiles in plasma, urine, and feces after a single oral administration of [14C]ICP-332 to healthy subjects, identify the main metabolites, and determine the metabolic pathways and elimination pathways of ICP-332 in the human body.
一项评价口服ICP-332在中度至重度特应性皮炎受试者中的有效性和安全性的随机、双盲、安慰剂对照的III期研究
[Translation] A randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of oral ICP-332 in subjects with moderate to severe atopic dermatitis
评价ICP-332在中度至重度特应性皮炎受试者中的疗效
[Translation] To evaluate the efficacy of ICP-332 in subjects with moderate to severe atopic dermatitis
一项评价ICP-332在中重度特应性皮炎患者中安全性、有效性、药代动力学和药效学特征的随机、双盲、安慰剂对照的II期临床试验
[Translation] A randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of ICP-332 in patients with moderate to severe atopic dermatitis
1.评估ICP-332治疗中重度特应性皮炎(AD)成人受试者的安全性和耐受性。
2.使用湿疹面积和严重程度指数(EASI)评分,评估ICP-332治疗中重度AD的疗效。
3.ICP-332 治疗中重度AD成人受试者其他疗效终点和患者报告的结果。
4.评估ICP-332 在中重度AD成人受试者中的药代动力学(PK)特征。
[Translation] 1. Evaluate the safety and tolerability of ICP-332 in the treatment of adult subjects with moderate to severe atopic dermatitis (AD).
2. Evaluate the efficacy of ICP-332 in the treatment of moderate to severe AD using the Eczema Area and Severity Index (EASI) score.
3. Other efficacy endpoints and patient-reported outcomes of ICP-332 in the treatment of adult subjects with moderate to severe AD.
4. Evaluate the pharmacokinetic (PK) characteristics of ICP-332 in adult subjects with moderate to severe AD.
100 Clinical Results associated with Guangzhou InnoCare Pharma Tech Co., Ltd.
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