NCT06704347

Safety Study of XT-150 in Participants With ALS

A Phase 1, Open-Label Study Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Single Ascending Dose Regimens of XT-150 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Xalud Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, multi-center safety study of XT-150 in adult participants with Amyotrophic Lateral Sclerosis (ALS). Participants providing informed consent and meeting all study eligibility criteria will be enrolled in the study and will receive a single injection of XT-150 at the Baseline visit. Follow-up visits will occur over 180 days (6 months) after the injection. 8 participants (4 participants per dose level) will be enrolled sequentially in up to 2 ascending, single dose cohorts: Cohort 1: 1.5 mg XT-150 Cohort 2: 4.5 mg XT-150

Detailed description

The main questions this study is aiming to answer are: * What adverse events are reported during this study? An adverse event is any "side effect" that participants have during a study. Adverse events may or may not be caused by XT-150. The study doctors will check participants' ALS and general health throughout the trial. * Does XT-150 have any effects on participants' physical examination findings, vital signs, or laboratory values? In addition to evaluating the safety of XT-150, this study will also collect samples to provide information on the following: * The levels of XT-150 in your body * The effect of XT-150 on cytokines including interleukin (IL)-10 * The effect of XT-150 on relevant ALS biomarkers such as Neurofilament Light (NfL) In addition, ALS functional score, breathing capacity and strength will be collected over the course of the study.

Conditions

• Amyotrophic Lateral Sclerosis (ALS)

Interventions

Type	Name	Description
BIOLOGICAL	XT-150	XT-150 is a small piece of plasmid DNA (genetic material) that produces a variant of the anti-inflammatory cytokine, Interleukin 10 (IL-10).

Timeline

• Start date: 2025-11-01
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2024-11-26
• Last updated: 2025-04-06

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study