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NCT07122453 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Lower Back Pain, sponsored by Centrexion Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
16
Enrollment target
1
Study location

NCT07122453 is a Phase 1 study of Lower Back Pain that is actively recruiting participants, run by Centrexion Therapeutics. The registered enrollment target is 16 participants, below the 24-participant average among 4 other Lower Back Pain trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT07122453, a Phase 1 study of Lower Back Pain, is actively recruiting participants, sponsored by Centrexion Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
16 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • DRUG Placebo
  • DRUG CNTX-3001

Study Locations (1)

California

  • Neurovations - Napa

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2026-03
Est. Completion 2027-01
Phase Phase 1

Sponsor

Centrexion Therapeutics

12 total trials

What the Registry Record Tells You About NCT07122453

The ClinicalTrials.gov registry entry for NCT07122453 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 24-participant average among 4 other Lower Back Pain trials with a reported enrollment target (33% lower). The listed sponsor is Centrexion Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Lower Back Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT07122453 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT07122453 about?

NCT07122453 is a clinical study titled "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 wheth...

What is the current status of trial NCT07122453?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2026-03. Estimated completion is 2027-01.

What conditions does trial NCT07122453 study?

This clinical trial studies the following conditions: Lower Back Pain.

What interventions are being tested in trial NCT07122453?

The interventions under investigation include: Placebo (DRUG), CNTX-3001 (DRUG).

Who is sponsoring clinical trial NCT07122453?

This trial is sponsored by Centrexion Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07122453 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.