drugset / Trial / NCT06506994

A Study of HRS-9057 in Patients With Heart Failure and Volume Overload

NCT06506994

Phase 1 Completed 25 enrolled Fujian Shengdi Pharmaceutical Co., Ltd.
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

EvaluationDrugModalityDoseRoute
Subject HRS-9057 Unknown
Subject Tolvaptan Small molecule

Indications