NCT07122453

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

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Single Ascending Doses of Intrathecal CNTX-3001 in Subjects With Intractable Chronic Moderate to Severe Low Back Pain

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Centrexion Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Lower Back Pain

Interventions

Type	Name	Description
DRUG	CNTX-3001	non-opioid analgesic
DRUG	Placebo	Placebo product

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-08-14
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study