Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506994
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-28
Brief Title:
A Study of HRS-9057 in Patients With Heart Failure and Volume Overload
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open Label Tolvaptan-controlled Phase I Study to Evaluate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Efficacy of Multiple Ascending Dose of HRS-9057 in Heart Failure With Volume Overload
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
The study is an open-label Tolvaptan-controlled Phase I study to evaluate the safety tolerability PKPD profile and efficacy of HRS-9057 in the treatment of heart failure with volume overload A total of 24 subjects who experience volume overload due to heart failure despite diuretic treatment will be enrolled in the study and receive HRS-9057 injection or Tolvaptan tablets
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