Safety and PK of Intrathecal CNTX-3001 for Intractable Chronic Low Back Pain

This clinical study is being conducted to evaluate the safety, tolerability, plasma pharmacokinetics and efficacy of an investigational drug called CNTX-3001. This Phase 1 study is the first time that CNTX-3001 will be given to people (first-in-human study). The study is being done to evaluate whether CNTX-3001, given into the intrathecal space by lumbar puncture, can be administered safely to participants who have been diagnosed with intractable chronic moderate to severe low back pain and who have not responded well to other treatments in the past. CNTX-3001 is a novel, non-opioid small molecule

NCT Number	NCT07122453
Lead Sponsor	Centrexion Therapeutics Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions	Lower Back Pain
Enrollment	16 participants
Start Date	2026-03
Primary Completion	2027-01 (estimated)
Study Completion	2027-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-23