| Trial ID: | L0291 |
| Source ID: | NCT05638126
|
| Associated Drug: |
Hrs-1780 Table Or Placebo
|
| Title: |
Safety and Tolerance of Increased Doses of HRS-1780 Tablets in Healthy Subjects
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease
|
| Interventions: |
DRUG: HRS-1780 table or placebo|DRUG: HRS-1780 table or placebo|DRUG: HRS-1780 table or placebo
|
| Outcome Measures: |
Primary: 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. | Secondary: 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|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
|
| Sponsor/Collaborators: |
Sponsor: Shandong Suncadia Medicine Co., Ltd.
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
96
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-02-02
|
| Completion Date: |
2023-12
|
| Results First Posted: |
|
| Last Update Posted: |
2023-10-25
|
| Locations: |
West China Hospital of Sichuan University, Chengdu, Sichuan, 610044, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05638126
|
