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

NCT06506994 | Completed Phase 1

• 1 other identifier: HRS-9057-103
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of any adverse events (AEs)

  baseline up to Day 14

Secondary Outcomes (12)

• Tmax for HRS-9057

  Predose on Day 1 through Day 6

• Cmax for HRS-9057

  Predose on Day 1 through Day 6

• Daily urine volume

  Predose on Day 1 through Day 7

• Daily fluid balance

  Predose on Day 1 through Day 7

• Serum sodium concentration

  Predose on Day 1 through Day 6

Study Arms (2)

Treatment group A: HRS-9057/ Tolvaptan

EXPERIMENTAL

Drug: HRS-9057; Drug: Tolvaptan

Treatment group B: HRS-9057/ Tolvaptan

EXPERIMENTAL

Drug: HRS-9057; Drug: Tolvaptan

Interventions

HRS-9057 DRUG

HRS-9057 injection dose 1

Treatment group A: HRS-9057/ Tolvaptan

Tolvaptan DRUG

Tolvaptan tablets

Treatment group A: HRS-9057/ Tolvaptan; Treatment group B: HRS-9057/ Tolvaptan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Medical history of myocardial infarction, acute decompensated heart failure, stroke, or transient ischemic attack within 30 days prior to or at screening;
• Hypovolemic hyponatremia.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510285, China

Location

MeSH Terms

Interventions

Tolvaptan

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HRS-9057 injection was compared with Tolvaptan tablets

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 18, 2024
• Study Start: August 16, 2024
• Primary Completion: October 29, 2025
• Study Completion: October 29, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (1)