Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2025-12-26 @ 1:20 PM
Study NCT ID:
NCT04238793
Status:
COMPLETED
Last Update Posted:
2024-07-29
First Post:
2019-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Ascending Doses Study of KLS-2031 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
Sponsor:
Kolon Life Science
Organization:
Study Overview
Official Title:
A Phase 1/2a, First-in-Human, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Therapeutic Activity of Single Ascending Doses of KLS-2031 Administered by Transforaminal Epidural Injection in Patients With Neuropathic Pain From Lumbosacral Radiculopathy
Status:
COMPLETED
Status Verified Date:
2024-07
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:
Escalating single-dose design study to determine the safety, tolerability, and analgesic activity of KLS-2031
Detailed Description:
This is a first-in-human (FIH), multicenter, double-blind, placebo-controlled, parallel-group, escalating single-dose design study to determine the safety, tolerability, and analgesic activity of KLS-2031 administered by transforaminal epidural injection to subjects aged 18 to 75 years with neuropathic pain due to LSR.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: