RecruitingPhase 1NCT07122453

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


Sponsor

Centrexion Therapeutics

Enrollment

16 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CNTX-3001 and a drug called Placebo for people with lower back pain. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCNTX-3001

non-opioid analgesic

DRUGPlacebo

Placebo product


Locations(1)

Neurovations

Napa, California, United States

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NCT07122453


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