ITX24-01 in Adult Male and Female Patients With Select Types of Severe Chronic Neck- and Lower Back Pain

NCT07520240 ↗

Phase 1 Not yet recruiting 32 enrolled Interventional AnalgesiX Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study is a single ascending dose (SAD), single-center, randomised, double-blind, placebo-controlled Phase 1b clinical trial designed to evaluate the safety, tolerability, and preliminary analgesic efficacy of ITX24-01 in patients with severe chronic zygapophysial joint pain (facet joint pain). The study consists of three dose escalation cohorts and one extension cohort.

Timeline

Start: 2026-06-01
Primary completion: 2027-01-31
Completion: 2027-04-30

Publications

Background Stojanovic MP, Higgins DM, Popescu A, Bogduk N. COMBI: a convenient tool for clinical outcome assessment in conventional practice. Pain Med. 2015 Mar;16(3):513-9. doi: 10.1111/pme.12581. Epub 2014 Oct 14. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ITX24-01	Unknown	—	Other

Indications

No indication recorded.