[Translation] An open-label, positive-controlled, dose-escalation Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of multiple-dose HRS-9057 for injection in patients with heart failure-induced fluid retention
主要目的:评估注射用 HRS-9057 在心力衰竭引起的体液潴留中多次给药的安全性和耐受性。
次要目的:评估注射用HRS-9057在心力衰竭引起的体液潴留中多次给药的药代动力学(PK)和药效动力学(PD)特征;评估注射用HRS-9057在心力衰竭引起的体液潴留中多次给药的有效性。
[Translation] Primary objective: To evaluate the safety and tolerability of multiple dosing of HRS-9057 for injection in fluid retention caused by heart failure.
Secondary objective: To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of multiple dosing of HRS-9057 for injection in fluid retention caused by heart failure; to evaluate the effectiveness of multiple dosing of HRS-9057 for injection in fluid retention caused by heart failure.