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

NCT06506994 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-11-17

No results posted yet for this study

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

  • Heart Failure With Volume Overload

Interventions

DRUG

HRS-9057

HRS-9057 injection dose 1

DRUG

HRS-9057

HRS-9057 injection dose 2

DRUG

Tolvaptan

Tolvaptan tablets

Sponsors & Collaborators

  • Fujian Shengdi Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-16
Primary Completion
2025-10-29
Completion
2025-10-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06506994 on ClinicalTrials.gov