NCT06506994CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 17 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 28 Jun 2024
- Start date
- 16 Aug 2024
- Primary completion date
- 29 Oct 2025
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Diseases
- Heart failure
- NCT number
- NCT06506994
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 25
- From 16 Aug 2024 to the primary completion date, 29 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medical history of myocardial infarction, acute decompensated heart failure, stroke, or transient ischemic attack within 30 days prior to or at screening;
Other
- Hypovolemic hyponatremia.
Who the study is looking for
- Male or female, age 18-75 years at the time of signing informed consent.
- Diagnosed as chronic heart failure at least 1 month prior to screening.
- Patients with CHF in whom lower limb edema, pulmonary congestion, jugular venous distension or hepatomegaly due to volume overload is present despite diuretics treatment.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The second Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.