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

NCT07520240 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

  • Facet Joint Pain

Interventions

DRUG

ITX24-01

Fluoroscopy guided local administration by the medial branch block (MBB) route. Dosage form: liquid. Frequency of administration: once (single dose).

DRUG

Normal Saline (0.9% NaCl)

Placebo (negative control). Dosage form: liquid. Frequency of administration: once (single dose).

Sponsors & Collaborators

  • Interventional AnalgesiX Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07520240 on ClinicalTrials.gov