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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)
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
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Barrow Neurological Institute (St. Joseph's)
Phoenix, Arizona, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Health
Detroit, Michigan, United States
Start Date
November 1, 2025
Primary Completion Date
March 1, 2027
Completion Date
March 1, 2027
Last Updated
April 6, 2025
8
ESTIMATED participants
XT-150
BIOLOGICAL
Lead Sponsor
Xalud Therapeutics, Inc.
NCT07187388
NCT07202494
Data Source & Attribution
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