一项在复发性/难治性T细胞淋巴瘤受试者中评价口服白细胞介素-2诱导性T细胞激酶抑制剂CPI-818的I/Ib期剂量递增试验
[Translation] A Phase I/Ib dose-escalation trial evaluating the oral interleukin-2-inducible T-cell kinase inhibitor CPI-818 in subjects with relapsed/refractory T-cell lymphoma
本研究的主要目的是确定CPI-818在递增剂量水平下的安全性和耐受性特征;确定CPI-818的最大耐受剂量(MTD)或最大给药剂量(MAD),以选择扩展队列剂量(ECD); 评估CPI-818在选定R/R T细胞淋巴瘤受试者中的安全性和耐受性。
[Translation] The primary objective of this study is to determine the safety and tolerability profile of CPI-818 at escalating dose levels; to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of CPI-818 for selection of expansion cohort doses (ECD); To evaluate the safety and tolerability of CPI-818 in selected subjects with R/R T-cell lymphoma.
ZN-d5单药用于中国非霍奇金淋巴瘤受试者的I期剂量递增研究
[Translation] Phase I dose escalation study of ZN-d5 monotherapy in Chinese subjects with non-Hodgkin lymphoma
? 评估ZN-d5在NHL受试者中的安全性和耐受性
? 确定NHL受试者的MTD和/或RP2D
? 确定ZN-d5在NHL受试者中的PK特征
? 评估ZN-d5在HNL受试者中的临床活性
[Translation] ? Assessing the safety and tolerability of ZN-d5 in NHL subjects
? Determination of MTD and/or RP2D in NHL subjects
? Determining the PK profile of ZN-d5 in NHL subjects
? Assessing the clinical activity of ZN-d5 in HNL subjects
一项评估TVB 2640(ASC40)用于非酒精性脂肪性肝炎患者治疗的随机、单盲、安慰剂对照、多中心、2期临床试验。
[Translation] A randomized, single-blind, placebo-controlled, multicenter, phase 2 clinical trial evaluating TVB 2640 (ASC40) in patients with nonalcoholic steatohepatitis.
1.通过磁共振成像质子密度脂肪分数(MRI-PDFF)测定非酒精性脂肪性肝炎(NASH)患者每日一次(QD)服用TVB-2640治疗12周,与安慰剂相比,对肝脂肪分数自基线变化的影响; 2.确定每日一次TVB-2640与安慰剂相比在NASH患者中的安全性,包括对丙氨酸氨基转移酶(ALT)和天冬氨酸氨基转移酶(AST)的影响。
[Translation] 1. Nonalcoholic steatohepatitis (NASH) patients treated with once-daily (QD) TVB-2640 for 12 weeks as measured by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) compared with placebo on liver fat fraction The effect of change from baseline; 2. To determine the safety of once-daily TVB-2640 compared with placebo in NASH patients, including on alanine aminotransferase (ALT) and aspartate aminotransferase (AST) Impact.
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100 Translational Medicine associated with Patheon Development Services, Inc.