Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06296095
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-06
First Post:
2023-07-17
Brief Title:
To Evaluate the Clinical Study of CUD005 Injection in Patients With Cirrhosis
Sponsor:
Anhui Provincial Hospital
Organization:
Anhui Provincial Hospital
Study Overview
Official Title:
A Single-center Single-arm Open-label Dose-escalation Clinical Study Evaluating the Safety Tolerability and Initial Efficacy of CUD005 Injection in Patients With Cirrhosis
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is a single-center single-arm open-label dose-escalation clinical study to evaluate the tolerability safety and preliminary efficacy of CUD005 injection in patients with cirrhosis
Detailed Description:
The study was designed according to the 33 principle with a total of 3 dose levels and dose escalation
Low-dose group 50107 cellstime Medium-dose group 15108 cellstime High-dose group 50108 cellstime Subjects were sequentially placed in 3 different dose groups administered as a single peripheral intravenous dose
According to the enrollment restriction design a total of a minimum of 9 subjects are expected to be enrolled and the final sample size depends on the number of DLT the number of dose groups ascended before DLT is observed and the MTD is determined
Low-dose group 50107 cellstime Medium-dose group 15108 cellstime High-dose group 50108 cellstime Subjects were sequentially placed in 3 different dose groups administered as a single peripheral intravenous dose
According to the enrollment restriction design a total of a minimum of 9 subjects are expected to be enrolled and the final sample size depends on the number of DLT the number of dose groups ascended before DLT is observed and the MTD is determined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None