Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-22 @ 9:08 AM
Study NCT ID:
NCT05524103
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2022-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety and Pharmacokinetics of ALMB-0166 in Patients With Acute Spinal Cord Injury
Sponsor:
AlaMab Therapeutics (Shanghai) Inc.
Organization:
Study Overview
Official Title:
A Phase Ⅰ, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ALMB-0166 in Patients With Acute Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2022-08
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:
None
Brief Summary:
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ALMB-0166 in patients with acute spinal cord injury.
Detailed Description:
This is a phase 1, randomized, double-blinded, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of ALMB-0166 in patients with acute spinal cord injury.
Study Oversight
Has Oversight DMC:
True
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?: