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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: Recruiting Phase 1 study of Lower Back Pain, sponsored by Centrexion Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Number of participants with TEAEs, which includes laboratory test variables
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CNTX-3001
Study Locations (1)
California
- Neurovations - Napa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2026-03 |
| Est. Completion | 2027-01 |
| Phase | Phase 1 |
What NCT07122453 shows while recruiting
NCT07122453 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 24-participant average among 4 other Lower Back Pain trials with a reported enrollment target (33% lower).
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 a single indexed study location in 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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