A Phase 1 interventional study of HRS-1780 in Chronic Kidney Disease, sponsored by Shandong Suncadia Medicine Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by Shandong Suncadia Medicine Co., Ltd. · Phase 1, Interventional, and Treatment
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 27 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Shandong Suncadia Medicine Co., Ltd. is the lead sponsor of 86 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Renal impairment subjects:
Exclusion Criteria:
Renal impairment subjects:
Drug: HRS-1780
Drug: HRS-1780
Drug: HRS-1780
Single dose in each arm
Pharmacokinetics-Cmax
Maximum observed concentration of HRS-1780
Time frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-AUC0-last
Area under the concentration-time curve from time 0 to last time point after HRS-1780 administration
Time frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-AUC0-inf
Area under the concentration-time curve from time 0 to infinity after HRS-1780 administration
Time frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-Tmax
Time to Cmax of HRS-1780
Time frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-t1/2
Terminal elimination half-life of HRS-1780
Time frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-CL/F
Apparent clearance of HRS-1780
Time frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-Vz/F
Apparent volume of distribution during terminal phase of HRS-1780
Time frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-Cumulative excretion (Ae)
Cumulative amount of HRS-1780 excreted in urine
Time frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-Cumulative excretion rate (Ae%)
Cumulative percentage of HRS-1780 recovered in urine
Time frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-Renal clearance (CLr)
Clearance of HRS-1780 by kidney
Time frame: Start of Treatment to end of study (approximately 1 week)
Binding rates of plasma protein (BRPP) of HRS-1780
Binding rates of plasma protein
Time frame: Start of Treatment to end of study (approximately 1 week)
Adverse events
Incidence and severity of adverse events
Time frame: Start of Treatment to end of study (approximately 1 week)
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Shandong Suncadia Medicine Co., Ltd.