drugset / Trial / NCT06704347

Safety Study of XT-150 in Participants With ALS

NCT06704347 ↗

Phase 1 Not yet recruiting 8 enrolled Xalud Therapeutics, Inc.
Non-randomizedSequentialOpen-labelTreatment

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

Timeline

Start
2025-11
Primary completion
2027-03
Completion
2027-03

Drugs

EvaluationDrugModalityDoseRoute
Subject XT-150 Other / unclassified 1.5 mg Intrathecal
Subject XT-150 Other / unclassified 4.5 mg Intrathecal