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A Multicenter, Non-randomized, Open-label, Parallel-controlled Study to Evaluate the Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function
This is a multicenter, non-randomized, open-label, parallel-controlled study. The main objective is to evaluate the safety and pharmacokinetics of HRS-1780 in subjects with mild and moderate renal impairment versus healthy subjects, and to provide a basis for dose selection of HRS-1780 in patients with chronic kidney disease.
Details
| Lead sponsor | Shandong Suncadia Medicine Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 27 |
| Start date | 2023-09 |
| Completion | 2023-12-08 |
Conditions
- Chronic Kidney Disease
Interventions
- HRS-1780
Primary outcomes
- Pharmacokinetics-Cmax — Start of Treatment to end of study (approximately 1 week)
Maximum observed concentration of HRS-1780 - Pharmacokinetics-AUC0-last — Start of Treatment to end of study (approximately 1 week)
Area under the concentration-time curve from time 0 to last time point after HRS-1780 administration - Pharmacokinetics-AUC0-inf — Start of Treatment to end of study (approximately 1 week)
Area under the concentration-time curve from time 0 to infinity after HRS-1780 administration