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

NCT04238793 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-07-29

No results posted yet for this study

Summary

Escalating single-dose design study to determine the safety, tolerability, and analgesic activity of KLS-2031

Conditions

  • Neuropathic Pain From Lumbosacral Radiculopathy

Interventions

DRUG

KLS-2031

KLS-2031 administered by transforaminal epidural injection

OTHER

Placebo

Normal Saline (0.9%) administered by transforaminal epidural injection

Sponsors & Collaborators

  • Kolon Life Science

    lead INDUSTRY

Principal Investigators

  • Todd Bertoch, MD · JBR Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-16
Primary Completion
2023-10-18
Completion
2023-10-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04238793 on ClinicalTrials.gov