NCT07520240

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

A Sequential, Single Ascending Dose, Phase 1b, Randomised, Double-Blind, 2-Arm Study to Investigate the Safety and Tolerability of ITX24-01 Compared With Placebo In Adult Male and Female Patients With Select Types of Severe Chronic Neck- And Lower Back Pain

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Interventional AnalgesiX Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Purpose: This is a Single Ascending Dose (SAD), Phase 1b, single-center, randomised, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and preliminary analgesic efficacy of ITX24-01 administered via the medial branch block (MBB) route in patients with severe chronic zygapophysial joint pain (facet joint pain). The study consists of three dose escalation cohorts and one extension cohort. Study Population: The study population will consist of patients with severe chronic zygapophysial joint pain who meet the specified inclusion and exclusion criteria. Blinding and Masking: The study employs a double-blind design, where both participants and investigators are blinded to treatment assignments. Masking will be applied to the assessor, investigator, caregiver, and participant to minimize bias. Randomization and Assignment: Participants will be randomised within each cohort to receive either ITX24-01 or a placebo. In each of the three dose escalation cohorts (Group 1: low dose, Group 2: intermediate dose, Group 3: full dose), 6 participants will receive ITX24-01 and 2 will receive placebo. Group 4 is an extension cohort consisting of 4 participants receiving ITX24-01 and 4 receiving placebo. Randomization occurs after the screening period and before the treatment administration. Dose-Escalation and Monitoring: Progression from one dose group to the next will only be allowed if the Maximum Tolerated Dose (MTD) has not been reached in the preceding group. A Safety Monitoring Committee (SMC) overseeing safety data will also function as dose-escalation committee reviewing and approving dose increases or -adjustments between groups. If at any dose level an MTD was encountered, doses in subsequent groups will be adjusted. Extension Cohort: Group 4 serves as an extension cohort, in which additional patients will receive ITX24-01 at the highest dose level at which no MTD was encountered in any of the previous groups. Accordingly, the highest possible dose administered to participants in the extension cohort will be the full dose. If a dose modification (lowering) was instituted at any time in the study, the dose will be lower. The extension cohort will thereby further assess safety and tolerability at the highest dose reached during dose escalation. Dose Modification: If the MTD is reached in any group, the dose for the subsequent group (or any subsequently enrolled patients in the same group) will be lowered to the dose level of the preceding group, i.e., the preceding lower dose level, at which no MTD had been encountered.

Conditions

• Facet Joint Pain

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-01-31
• Completion: 2027-04-30
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: Australia