Nanjing Han Xin Pharmaceutical Technology Co., Ltd.

Primary objective: To evaluate the safety and tolerability of AC02 for injection after single/multiple administration in healthy subjects. Secondary objectives: To evaluate the pharmacokinetic and pharmacodynamic characteristics of AC02 for injection after single/multiple administration in healthy subjects; To evaluate the immunogenicity characteristics of AC02 for injection after single/multiple administration in healthy subjects; To evaluate the effect of AC02 for injection on the QTc interval in healthy subjects.

Main purpose: Using Iguratimod tablets (specification: 25 mg) produced by Nanjing Chengong Pharmaceutical Co., Ltd. as the test preparation, and using Iguratimod tablets (trade name: Edexin, specification: 25 mg) certified by Hainan Xiansheng Pharmaceutical Co., Ltd. as the reference preparation, a human bioequivalence test was conducted under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects. Secondary purpose: Observe the safety of the test preparation and the reference preparation in healthy subjects.

Amoxicillin-clavulanate potassium dry suspension produced by Nanjing Chengong Pharmaceutical Co., Ltd. was used as the test preparation, and amoxicillin-clavulanate potassium dry suspension produced by SmithKline Beecham Limited was used as the reference preparation. The bioequivalence of the two preparations in humans was evaluated through a single-center, randomized, open-label study.