drugset / Trial / NCT06506994
A Study of HRS-9057 in Patients With Heart Failure and Volume Overload
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-08-16
- Primary completion
- 2025-10-29
- Completion
- 2025-10-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HRS-9057 | Unknown | — | — |
| Subject | Tolvaptan | Small molecule | — | — |