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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: HRS-9057/ Tolvaptan | Experimental |
| |
| Treatment group B: HRS-9057/ Tolvaptan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-9057 | Drug | HRS-9057 injection dose 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of any adverse events (AEs) | baseline up to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510285 | China |
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| ID | Term |
|---|---|
| D000077602 | Tolvaptan |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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HRS-9057 injection was compared with Tolvaptan tablets
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| HRS-9057 |
| Drug |
HRS-9057 injection dose 2 |
|
| Tolvaptan | Drug | Tolvaptan tablets |
|
| Predose on Day 1 through Day 7 |
| Daily fluid balance | Daily fluid balance is calculated by subtracting daily urine volume from daily fluid intake. | Predose on Day 1 through Day 7 |
| Serum sodium concentration | 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 |
| Body weight | baseline to Day 8 |
| Lower limb edema change from baseline | The severity of edema in the subject's tibial border or dorsum of the foot will be assessed in the sitting position using a 4-point scale (0-absent, 1-mild, 2-moderate and 3-severe) by the investigator. The percentage of subjects in whom the lower limb edema was improved or worsening at Day 8 will be evaluated. | baseline to Day 8 |
| Jugular venous distension change from baseline | Whether or not the subject has jugular venous distension will be documented. If distension is observed, the vertical height (in centimeters) from the sternal angle to the highest point of pulsation of the internal jugular vein will be documented and the change from baseline to Day 8 will be evaluated. | baseline to Day 8 |
| Pulmonary congestion change from baseline | The investigator will perform chest X-ray at baseline and Day 8 to assess the severity of pulmonary congestion using a 4-point scale (0-absent, 1-mild, 2-moderate and 3-severe). The percentage of subjects in whom pulmonary congestion was improved or worsening at Day 8 will be evaluated. | baseline to Day 8 |
| New York Heart Association (NYHA) classification change from baseline | baseline to Day 8 |