clinical trial · NCT06506994
A Study of HRS-9057 in Patients With Heart Failure and Volume Overload
Fujian Shengdi Pharmaceutical Co., Ltd.·phase1·completed·n = 25
Heart Failure With Volume OverloadHRS-9057HRS-9057Tolvaptan
brief summary
The study is an open-label, Tolvaptan-controlled Phase I study to evaluate the safety, tolerability, PK/PD profile and efficacy of HRS-9057 in the treatment of heart failure with volume overload. A total of 24 subjects who experience volume overload due to heart failure despite diuretic treatment will be enrolled in the study and receive HRS-9057 injection or Tolvaptan tablets.
started
Aug 16, 2024
primary completion
Oct 29, 2025
completion
Oct 29, 2025
last updated
Nov 17, 2025
official title
An Open Label, Tolvaptan-controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Ascending Dose of HRS-9057 in Heart Failure With Volume Overload
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol