NCT06506994CompletedPhase 1
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
Fujian Shengdi Pharmaceutical Co., Ltd.1 site in 1 country25 target enrollmentStarted: August 16, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- The incidence and severity of any adverse events (AEs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Medical history of myocardial infarction, acute decompensated heart failure, stroke, or transient ischemic attack within 30 days prior to or at screening;
- •Hypovolemic hyponatremia.
Arms & Interventions
Treatment group A: HRS-9057/ Tolvaptan
Experimental
Intervention: HRS-9057 (Drug)
Treatment group A: HRS-9057/ Tolvaptan
Experimental
Intervention: Tolvaptan (Drug)
Treatment group B: HRS-9057/ Tolvaptan
Experimental
Intervention: HRS-9057 (Drug)
Treatment group B: HRS-9057/ Tolvaptan
Experimental
Intervention: Tolvaptan (Drug)
Outcomes
Primary Outcomes
The incidence and severity of any adverse events (AEs)
Time Frame: baseline up to Day 14
Secondary Outcomes
- Cmax for HRS-9057(Predose on Day 1 through Day 6)
- Serum osmolality(Predose on Day 1 through Day 6)
- Urine osmolality(Predose on Day 1 through Day 7)
- Jugular venous distension change from baseline(baseline to Day 8)
- Tmax for HRS-9057(Predose on Day 1 through Day 6)
- Serum sodium concentration(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)
- Body weight(baseline to Day 8)
- New York Heart Association (NYHA) classification change from baseline(baseline to Day 8)
- Lower limb edema change from baseline(baseline to Day 8)
- Pulmonary congestion change from baseline(baseline to Day 8)
Investigators
Study Sites (1)
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