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Safety and PK of Intrathecal CNTX-3001 for Intractable Chronic Low Back Pain
NCT07122453 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2026-03 |
| Est. Completion | 2027-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07122453
The ClinicalTrials.gov registry entry for NCT07122453 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Centrexion Therapeutics, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07122453 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07122453?
The interventions under investigation include: Placebo (DRUG), CNTX-3001 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07122453?
This trial is sponsored by Centrexion Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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