Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453668
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-06
Brief Title:
A Study of TCD601 Siplizumab in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis ALS Patients
Sponsor:
ITB-Med LLC
Organization:
ITB-Med LLC
Study Overview
Official Title:
A 52-week Phase 1 Safety Pharmacokinetic and Pharmacodynamic Trial of Siplizumab in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis ALS Patients AURORA
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
AURORA
Brief Summary:
The purpose of this study is to investigate the safety pharmacokinetics PK and pharmacodynamics PD of TCD601 siplizumab in newly diagnosed adult ALS patients
Detailed Description:
None
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