NCT04238793

Single Ascending Doses Study of KLS-2031 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Kolon Life Science · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuropathic Pain From Lumbosacral Radiculopathy

Interventions

Type	Name	Description
DRUG	KLS-2031	KLS-2031 administered by transforaminal epidural injection
OTHER	Placebo	Normal Saline (0.9%) administered by transforaminal epidural injection

Timeline

• Start date: 2020-04-16
• Primary completion: 2023-10-18
• Completion: 2023-10-18
• First posted: 2020-01-23
• Last updated: 2024-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study