/ Not yet recruitingPhase 3 一项评价YK-1169治疗碳青霉烯类耐药革兰阴性菌引起的复杂性腹腔感染/血流感染的有效性与安全性随机、双盲、阳性药物平行对照、多中心Ⅲ期临床试验
[Translation] A randomized, double-blind, active drug parallel-controlled, multicenter Phase III clinical trial to evaluate the efficacy and safety of YK-1169 in the treatment of complicated intra-abdominal infection/bloodstream infection caused by carbapenem-resistant Gram-negative bacteria
主要研究目的:
评价YK-1169治疗碳青霉烯类耐药革兰阴性菌引起的复杂性腹腔感染/血流感染的有效性。
次要研究目的:
评价YK-1169治疗碳青霉烯类耐药革兰阴性菌引起的复杂性腹腔感染/血流感染的安全性。
[Translation] Primary study objective:
To evaluate the efficacy of YK-1169 in the treatment of complicated intra-abdominal infection/bloodstream infection caused by carbapenem-resistant Gram-negative bacteria.
Secondary study objective:
To evaluate the safety of YK-1169 in the treatment of complicated intra-abdominal infection/bloodstream infection caused by carbapenem-resistant Gram-negative bacteria.
YK-1169健康人体耐受性、药动学及药物相互作用研究
[Translation] Study on the tolerability, pharmacokinetics and drug interactions of YK-1169 in healthy humans
拟在健康受试者中开展随机、单盲、剂量递增、安慰剂对照的耐受、药动学及药物相互作用研究,评价YK-1169在健康受试者中单次、多次给药的安全性及耐受性、单次及多次给药在健康受试者体内的药动学特征、及头孢吡肟与阿维巴坦之间的药物相互作用。
[Translation] It is planned to conduct a randomized, single-blind, dose-escalation, placebo-controlled tolerance, pharmacokinetics and drug interaction study in healthy subjects to evaluate the safety and tolerability of single and multiple doses of YK-1169 in healthy subjects, the pharmacokinetic characteristics of single and multiple doses in healthy subjects, and the drug interaction between cefepime and avibactam.
100 Clinical Results associated with Nanjing Libowei Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Nanjing Libowei Pharmaceutical Co., Ltd.
100 Deals associated with Nanjing Libowei Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Nanjing Libowei Pharmaceutical Co., Ltd.