Beijing Kanghong Biological Medicine Co., Ltd.

Primary purpose: To evaluate the safety and tolerability of KH801 injection in the treatment of patients with advanced solid tumors, and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended dose (RP2D) for Phase II clinical trials. Secondary purpose: 1. To evaluate the pharmacokinetic characteristics of KH801 injection; 2. To evaluate the immunogenicity of KH801 injection; 3. To evaluate the preliminary efficacy of KH801 injection in the treatment of advanced solid tumors. Exploratory purpose: 4. To explore biomarkers of the anti-tumor effect of KH801 injection.

Primary objective: To compare the in vivo pharmacokinetic characteristics of KH917 injection (specification: 80 mg (1 ml)/vial) developed by Beijing Kanghong Biopharmaceutical Co., Ltd. and TuoZhi® (specification: 80 mg/mL) developed by Eli Lilly and Company after a single subcutaneous injection in healthy Chinese male subjects. Secondary objective: To compare the safety and immunogenicity of KH917 injection and TuoZhi® after a single subcutaneous injection in healthy Chinese male subjects.