Nanjing YOKO Pharmaceutical Co., Ltd.

To investigate the pharmacokinetic characteristics of clevidipine butyrate fat emulsion injection from Nanjing Youke Pharmaceutical Co., Ltd. in Chinese healthy subjects. A comparative pharmacokinetic study was conducted with clevidipine butyrate fat emulsion injection (trade name: Cleviprex®) from CHIESI USA INC, and its safety was evaluated.

To evaluate the safety and tolerability of YK-2168 in the treatment of advanced or unresectable solid tumors and patients with relapsed and/or refractory non-Hodgkin lymphoma, and to explore the maximum tolerated dose (MTD) of YK-2168, Determine the recommended dose (RP2D) for phase II clinical trials. To evaluate the pharmacokinetic (PK) profile of YK-2168. According to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1) or the Response Evaluation Criteria for Lymphoma (Lugano2014), the antitumor efficacy of YK-2168 was preliminarily evaluated by objective response rate (ORR) and disease control rate (DCR).

A randomized, single-blind, dose-escalating, placebo-controlled study of tolerance, pharmacokinetics and drug interactions in healthy subjects is planned to evaluate the efficacy of single and multiple doses of YK-1169 in healthy subjects. Safety and tolerability, single- and multiple-dose pharmacokinetics in healthy subjects, and drug interactions between cefepime and avibactam.