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作用机制SARS-CoV-2 3CLpro 抑制剂 |
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非在研适应症- |
最高研发阶段临床3期 |
首次获批国家/地区- |
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非在研适应症- |
最高研发阶段临床3期 |
首次获批国家/地区- |
首次获批日期- |
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非在研适应症- |
最高研发阶段临床1/2期 |
首次获批国家/地区- |
首次获批日期- |
A Multicenter, Open, Dose Escalation and Dose Expansion Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML)
This is a first-in-human, dose-escalation and dose-expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of STI-8591 in subjects with advanced AML who have signed an informed consent form (ICF) and have been screened for enrollment in this study.
Dose escalation phase: rapid titration and conventional 3+3 test design were used to evaluate the safety, dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and PK characteristics of STI-8591.
Dose Expansion Phase: Evaluate the safety, preliminary efficacy and determine the recommended phase II dose (RP2D) of STI-8591 for the treatment of subjects with advanced AML under the conditions of reaching the expanded dose.
一项评价STI-8591在晚期急性髓系白血病(AML)受试者中的安全性、耐受性、药代动力学和有效性的多中心、开放性、剂量递增和剂量扩展的I期研究
1.主要目的:评估STI-8591在晚期AML受试者中的安全性和耐受性
2.次要目的:确定STI-8591在晚期AML受试者中的RP2D;评估STI-8591及其主要代谢产物(如有)在晚期AML中的药代动力学特征;评估STI-8591在晚期AML中的生物标志物相对基线改变百分比;评估STI-8591在晚期AML中的初步有效性
A Randomized, Open, Two-sequence, Two-cycle, Double-cross Design Bioequivalence Trial of Fasting Single Oral STI-1558 Capsule in Healthy Chinese Subjects
This study is a randomized, open, single-dose, two-sequence, two-cycle, double-cross design bioequivalence study.
32 eligible subjects will be randomly assigned to TR group and RT group in a 1:1 ratio. Subjects in the TR group will take the test preparation (T) 200 mg/ pill × 1 pill on day 1 (D1) and the reference preparation (R) 200 mg/ pill × 1 pill on day 8 (D8). The sequence of medication in RT group is reversed from TR group. Wash for at least 7 days between doses.
Screening was performed within 28 days prior to initial dosing, and all eligible subjects were admitted to the clinical research Center 1 day prior to Cycle 1 dosing (D-1) and discharged on day 10 of the study (D10) after completing Cycle 2 PK blood collection, corresponding safety examination, and evaluation. On the 14th day of the study (± 1 day), the clinical research center was returned for follow-up to further evaluate the safety and tolerability of the subjects.
100 项与 浙江艾森药业有限公司 相关的临床结果
0 项与 浙江艾森药业有限公司 相关的专利(医药)
100 项与 浙江艾森药业有限公司 相关的药物交易
100 项与 浙江艾森药业有限公司 相关的转化医学