Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657560
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-23
Brief Title:
Pharmacokinetics Dialysability and Safety of HRS-9231 in Healthy Volunteers and in Patients With Impaired Renal Function
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pharmacokinetics PK Study of HRS-9231 Injection in Chinese Subjects With Renal Impairment and Normal Renal Function
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label non-randomized parallel cohorts design multicenter single dose phase I study
The primary objectives are
To evaluate the pharmacokinetics plasma and urine profile of HRS-9231 following single intravenous injection 005 mmolkg body weight in patients with mild to severe renal impairment and in healthy volunteers with normal renal function used as reference
To assess dialysability of HRS-923 following a single intravenous injection 005 mmolkg body weight in patients with end stage renal disease requiring hemodialysis
The primary objectives are
To evaluate the pharmacokinetics plasma and urine profile of HRS-9231 following single intravenous injection 005 mmolkg body weight in patients with mild to severe renal impairment and in healthy volunteers with normal renal function used as reference
To assess dialysability of HRS-923 following a single intravenous injection 005 mmolkg body weight in patients with end stage renal disease requiring hemodialysis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None