Ignite Creation Date:
2024-05-06 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05238532
Status:
WITHDRAWN
Last Update Posted:
2023-04-04
First Post:
2022-02-03
Brief Title:
Clinical Trial to Evaluate the Safety Tolerability and Efficacy of CT303 in Patients With ARDS
Sponsor:
GC Cell Corporation
Organization:
GC Cell Corporation
Study Overview
Official Title:
A Multi-center Open-label Dose-escalation and Dose-finding Phase I Clinical Trial to Evaluate the Safety Tolerability and Efficacy of CT303 in Patients With Acute Respiratory Distress Syndrome
Status:
WITHDRAWN
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulties in recruiting Subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluate the safety tolerability efficacy and pharmacodynamicspharmacokinetic properties of CT303 in patients with ARDS
Detailed Description:
This study is a multi-center open-label dose-escalation and dose-finding phase 1 clinical trial
The primary purpose is to evaluate the safety and tolerability of CT303 and the Secondary purpose is to evaluate the efficacy of CT303 in patients with ARDS And the exploratory purpose is to evaluate pharmacodynamics properties pharmacokinetic properties of CT303 in patients with ARDS
The primary purpose is to evaluate the safety and tolerability of CT303 and the Secondary purpose is to evaluate the efficacy of CT303 in patients with ARDS And the exploratory purpose is to evaluate pharmacodynamics properties pharmacokinetic properties of CT303 in patients with ARDS
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