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Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
中国健康受试者单次静脉滴注(IV)BJY-801的药代动力学研究
[Translation] Pharmacokinetic study of single intravenous (IV) infusion of BJY-801 in Chinese healthy subjects
评估中国健康受试者单次静脉滴注(Ⅳ)给药后BJY-801的安全性、耐受性及药代动力学特征。
[Translation] To evaluate the safety, tolerability and pharmacokinetics of BJY-801 after a single intravenous infusion (IV) administration in healthy Chinese subjects.
中国健康受试者单次静脉滴注BJY-801的耐受性研究
[Translation] Tolerability study of single intravenous infusion of BJY-801 in Chinese healthy subjects
根据非临床研究及已完成临床研究(MLFT-protocol-01)数据分析判断,需进一步探索BJY-801在中国成年健康人体单次给药的安全剂量范围,评估健康人体单次静脉滴注BJY-801的安全性和耐受性,为制定多次耐受和药代动力学研究及Ⅱ期临床试验给药方案提供依据。
[Translation] According to the data analysis and judgment of non-clinical research and completed clinical research (MLFT-protocol-01), it is necessary to further explore the safe dose range of BJY-801 for a single administration of BJY-801 in Chinese adult healthy subjects, and to evaluate a single intravenous infusion of BJY-801 in healthy subjects. The safety and tolerability of 801 provide a basis for formulating multiple tolerance and pharmacokinetic studies and dosing regimens for phase II clinical trials.
中国健康志愿者单次静滴注射用吗利福肽的耐受性和药代动力学研究临床试验
[Translation] Clinical Trial of Tolerability and Pharmacokinetics of Morifatide for Single Intravenous Infusion in Chinese Healthy Volunteers
观察健康人体单次接受滴注注射用吗利福肽的安全性和耐受性,评估注射用吗利福肽在健康人体单次给药的安全剂量范围及其在中国健康人体内的药代动力学特征,为制定多次耐受和药代动力学研究及II期临床试验给药方案提供依据。
[Translation] To observe the safety and tolerability of molifatide for injection in a single infusion in healthy subjects, and to evaluate the safe dose range of monorifatide for injection in healthy subjects and its pharmacokinetics in healthy subjects in China The kinetic characteristics provide a basis for formulating multiple tolerance and pharmacokinetic studies and dosing regimens for phase II clinical trials.
100 Clinical Results associated with Guangdong 8plus1 Medicine Co Ltd
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100 Translational Medicine associated with Guangdong 8plus1 Medicine Co Ltd