18 Participants Needed

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

Recruiting at 1 trial location
KL
Overseen ByKolon Life Science
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Kolon Life Science
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, KLS-2031, on adults with lower back nerve pain. The drug is injected into the spine to see if it can safely reduce pain by targeting the nerves directly.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

TB

Todd Bertoch, MD

Principal Investigator

JBR Clinical Research

Eligibility Criteria

Inclusion Criteria

The subject must be willing to provide written informed consent for study participation including the 1-year double-blind treatment period and 1-year, open-label, long-term extension period. Informed consent must be obtained before any screening activities are conducted.
The subject may be male or female but must be between the ages of 18 and 75 years, inclusive.
The subject must have a body mass index of ≤35 kg/m2.
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Exclusion Criteria

Note: Any question regarding the acceptability of the etiology of the neuropathic pain should be discussed with the medical monitor.
You have narrowing in the lower back (lumbar stenosis) that causes pain only when you walk. If your MRI shows narrowing but your pain is not only when walking, you can still participate.
You have difficulty accurately identifying and describing your own pain in different parts of your body.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of KLS-2031 or placebo via transforaminal epidural injection

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

104 weeks
Multiple visits at Week 1, 2, 4, 12, 26, 52, 78, 104

Treatment Details

Interventions

  • KLS-2031
  • Placebo
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment2 Interventions
Dose 3 (high dose: 1×1013 VG/500 μL solution) or Placebo
Group II: Cohort 2Experimental Treatment2 Interventions
Dose 2 (medium dose: 1×1012 VG/500 μL solution) or Placebo
Group III: Cohort 1Experimental Treatment2 Interventions
Dose 1 (low dose: 1×1011 VG/500 μL solution) or Placebo

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kolon Life Science

Lead Sponsor

Trials
9
Recruited
3,400+