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评价静脉注射药物BT-114143在健康受试者中的安全性、耐受性、药代动力学及生物学效应探索性研究I期临床试验
[Translation] Phase I clinical trial of an exploratory study to evaluate the safety, tolerability, pharmacokinetics and biological effects of intravenous drug BT-114143 in healthy subjects
1.单次给药与多次给药剂量递增试验 主要目的:评估BT-114143在健康受试者中静脉注射单次给药、多次给药剂量递增的安全性和耐受性,确定II期推荐剂量(RP2D)。 次要目的:评估BT-114143在健康受试者中静脉注射单次给药、多次给药剂量递增的药代动力学特征。 探索性目的:探索BT-114143在健康受试者中的生物学效应;探索BT-114143在健康受试者中的剂量-暴露-效应关系。
2.生物学效应探索性试验 主要目的:比较BT-114143与阳性对照药物单次静脉注射在健康受试者体内的抗纤溶活性和凝血指标,尽早建立药物的剂量-暴露-效应关系,为后期临床研究设计提供依据。 次要目的:评估BT-114143和阳性对照药物在健康受试者中静脉注射给药的药代动力学特征。
[Translation] 1. Single-dose and multiple-dose dose-escalation trials Main purpose: To evaluate the safety and tolerability of single-dose and multiple-dose dose-escalation of BT-114143 in healthy subjects, determine II recommended dose (RP2D). Secondary objectives: To evaluate the pharmacokinetics of BT-114143 in healthy subjects with single-dose, multiple-dose dose escalation by intravenous injection. Exploratory purposes: To explore the biological effects of BT-114143 in healthy subjects; to explore the dose-exposure-response relationship of BT-114143 in healthy subjects.
2. The main purpose of the biological effect exploratory test is to compare the antifibrinolytic activity and coagulation indexes of BT-114143 and the positive control drug after a single intravenous injection in healthy subjects, and to establish the dose-exposure-effect relationship of the drug as soon as possible. Provide the basis for the design of later clinical studies. Secondary objective: To evaluate the pharmacokinetics of BT-114143 and active control drug administered intravenously in healthy subjects.
BT-1053在复发/难治B细胞淋巴瘤患者中的耐受性与药代动力学I期临床研究
[Translation] Phase I clinical study of tolerability and pharmacokinetics of BT-1053 in patients with relapsed/refractory B-cell lymphoma
主要目的是评估BT-1053单药口服给药在复发/难治B细胞淋巴瘤患者中的安全性和耐受性,以确定最大耐受剂量(MTD)和推荐II期临床研究的使用剂量(RP2D)。次要目的是确定BT-1053在复发/难治B细胞淋巴瘤患者中的药代动力学参数,初步评估BT-1053在部分复发/难治B细胞性非霍奇金瘤亚型中的总体有效率。
[Translation] The primary objective is to evaluate the safety and tolerability of BT-1053 single-agent oral administration in patients with relapsed/refractory B-cell lymphoma, to determine the maximum tolerated dose (MTD) and the recommended dose for phase II clinical studies ( RP2D). Secondary objectives are to determine the pharmacokinetic parameters of BT-1053 in patients with relapsed/refractory B-cell lymphoma and to initially assess the overall efficacy of BT-1053 in some subtypes of relapsed/refractory B-cell non-Hodgkin tumor Efficient.
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100 Translational Medicine associated with ScinnoHub Pharmaceutical Co., Ltd.