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This is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-1780 in healthy subjects, and to evaluate the food effect on PK of HRS-1780.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | HRS-1780 table or placebo single dose |
|
| Part 2 | Experimental | HRS-1780 table or placebo single dose with food effect |
|
| Part 3 | Experimental | HRS-1780 table or placebo multiple dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-1780 table or placebo | Drug | HRS-1780 table or placebo single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the incidence and severity of adverse events in healthy subjects after single and multiple doses of HRS-1780 tablets | About a month from the first medication to the evaluation. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the concentration of HRS-1780 in plasma and urine | About 4 weeks after the first dose | |
| Evaluation of AUC0-t of HRS-1780 in plasma and urine | About 4 weeks after the first dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39155700 | Derived | Shen Q, Li L, Qian W, Dong X, Bao M, Huang R, Li N, Ye Z, Cheng G, Wang Q, Shen K, Luo Z. A four-in-one first-in-human study to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and concentration-QTc relationship of HRS-1780, a selective non-steroidal mineralocorticoid receptor antagonist, in healthy men. Expert Opin Investig Drugs. 2024 Oct;33(10):1083-1093. doi: 10.1080/13543784.2024.2393867. Epub 2024 Aug 26. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| HRS-1780 table or placebo |
| Drug |
HRS-1780 table or placebo single dose with food effect |
|
| HRS-1780 table or placebo | Drug | HRS-1780 table or placebo multiple dose |
|
| Evaluation of AUC0-∞ of HRS-1780 in plasma and urine |
| About 4 weeks after the first dose |
| Evaluation of Tmax of HRS-1780 in plasma and urine | About 4 weeks after the first dose |
| Evaluation of Cmax of HRS-1780 in plasma and urine | About 4 weeks after the first dose |
| Evaluation of t1/2 of HRS-1780 in plasma and urine | About 4 weeks after the first dose |
| Evaluate the blood pressure of subjects over time after HRS-1780 administration | About 4 weeks after the first dose |
| Evaluate the heart rate of subjects over time after HRS-1780 administration | About 4 weeks after the first dose |
| Evaluate the concentrations of plasma renin activity of subjects over time after HRS-1780 administration | About 4 weeks after the first dose |
| Evaluate the plasma aldosterone of subjects over time after HRS-1780 administration | About 4 weeks after the first dose |
| Evaluate the plasma angiotensin II of subjects over time after HRS-1780 administration | About 4 weeks after the first dose |
| Evaluate the urinary creatinine curve of subjects with time after HRS-1780 administration | About 4 weeks after the first dose |
| Evaluate the change curve of urine creatinine over time relative to baseline in subjects after HRS-1780 administration | About 4 weeks after the first dose |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |