Trials / Completed
CompletedNCT06506994
A Study of HRS-9057 in Patients With Heart Failure and Volume Overload
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HRS-9057 | HRS-9057 injection dose 1 |
| DRUG | HRS-9057 | HRS-9057 injection dose 2 |
| DRUG | Tolvaptan | Tolvaptan tablets |
Timeline
- Start date
- 2024-08-16
- Primary completion
- 2025-10-29
- Completion
- 2025-10-29
- First posted
- 2024-07-18
- Last updated
- 2025-11-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06506994. Inclusion in this directory is not an endorsement.