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

• Status: Recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kolon Life Science

Criteria

Inclusion Criteria:

To be eligible for the study, subjects must meet all of the following criteria at the screening visit:

1. 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.

2. The subject may be male or female but must be between the ages of 18 and 75 years, inclusive.

3. The subject must have a body mass index of ≤35 kg/m2.

4. The subject must have a diagnosis of pain due to LSR

5. The duration of pain since onset is ≥6 months.

Exclusion Criteria:

1. The subject has:

1. Neuropathic pain due to causes other than that specified in the inclusion criteria (eg, postherpetic neuralgia; painful diabetic neuropathy; mononeuritis multiplex; central poststroke pain; spinal abscess, infection, hematoma, spondylolisthesis with displacement, or malignancy; phantom limb pain; peripheral neuropathy due to alcoholism, malignancy, human immunodeficiency virus [HIV], syphilis; drug abuse; vitamin B12 deficiency; hypothyroidism; liver disease; toxic exposure).

2. Radicular pain at more than 1 spinal level, unstable spine, spondylolisthesis (> grade 1), spondylolysis, caudal equina syndrome, arachnoiditis, progressive neurological deficit, moderate to severe central spinal canal stenosis (congenital or acquired) from other origins, vertebral compression fracture(s).

3. Pain that is associated with a substantial somatic pain component in lower limbs or other parts of the body apart from the back (eg, non-neuropathic/musculoskeletal pain) or more than 1 cause or potential cause for pain symptoms in low limbs.

4. Any painful concurrent rheumatic disease such as, but not limited to, fibromyalgia, rheumatoid arthritis, or osteoarthritis that in the investigator's opinion would prevent the subject from reliably delineating or assessing his/her pain due to LSR.

Note: Any question regarding the acceptability of the etiology of the neuropathic pain should be discussed with the medical monitor.

2. Has lumbar stenosis with pain present solely upon walking. Presence of lumbar narrowing on MRI is acceptable if the pain is not solely present upon walking.

3. In the investigator's opinion, the subject is unable to reliably delineate or assess his/her own pain by anatomical location/distribution (eg, the subject cannot reliably tell the difference between his/her back pain and lower limb pain and cannot rate the intensity of each separately).