Nanjing Carephar Pharmaceutical Co., Ltd.

Primary purpose: For patients with upper gastrointestinal bleeding caused by acute gastric and/or duodenal ulcer and high risk of rebleeding, the drug is given after endoscopic treatment to evaluate the effectiveness of H009 injection in reducing the risk of rebleeding, which is non-inferior to esomeprazole sodium for injection (ESO); Secondary purpose: 1) Compared with ESO for injection, H009 injection is given after endoscopic treatment to patients with upper gastrointestinal bleeding caused by acute gastric and/or duodenal ulcer and high risk of rebleeding to evaluate the effect on rebleeding-related events; 2) Compared with ESO for injection, observe the safety of H009 injection for upper gastrointestinal bleeding caused by acute gastric and/or duodenal ulcer.

Primary objective: To evaluate the effectiveness of H009 injection with different dosage regimens in reducing the risk of rebleeding in patients with acute gastric and/or duodenal ulcer upper gastrointestinal bleeding and high risk of rebleeding after endoscopic treatment compared with Esomeprazole sodium for injection (ESO); Secondary objective: To evaluate the effect of H009 injection with different dosage regimens in reducing the risk of rebleeding in patients with acute gastric and/or duodenal ulcer upper gastrointestinal bleeding and high risk of rebleeding after endoscopic treatment compared with ESO for injection; To observe the safety of H009 injection with different dosage regimens in patients with acute gastric and/or duodenal ulcer upper gastrointestinal bleeding compared with ESO for injection; To observe the population pharmacokinetic characteristics of H009 injection in patients with peptic ulcer bleeding.

Study the safety and tolerability of H009 injection after multiple administration in healthy adult subjects; Observe the PK and PD characteristics of H009 injection after multiple administration in healthy adult subjects, and make a preliminary comparison with positive drugs to provide a basis for dose selection in later clinical studies.