Renkangya (Shenzhen) Biomedical Technology Co., Ltd.

Primary objective: To explore the efficacy and safety of GNPs for injection in patients with acute decompensated heart failure. Secondary objectives: (1) To explore the pharmacokinetic characteristics of GNPs for injection in patients with acute decompensated heart failure; (2) To explore the immunogenicity characteristics of GNPs for injection in patients with acute decompensated heart failure;

Primary objective: To evaluate the safety and tolerability of GNPs after single-ascending doses in healthy adult Chinese subjects and compare with placebo. Secondary objectives: (1) To evaluate the pharmacokinetic parameters of GNPs after single-ascending doses in healthy subjects. (2) To evaluate the pharmacodynamic characteristics of GNPs after single-ascending doses in healthy subjects. (3) To evaluate the immunogenicity characteristics of GNPs after single-ascending doses in healthy subjects. Exploratory objective: To explore the dose-response relationship between drug dose exposure and drug effect using model guidance.

Taking the effective rate of improvement of dyspnea at 24 hours after administration as the primary efficacy indicator, the differences in the efficacy of different doses of injectable GNP compared with the placebo group in patients with acute heart failure were explored to provide a basis for dose selection in Phase III clinical trials.