drugset / Trial / NCT06704347
Safety Study of XT-150 in Participants With ALS
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | XT-150 | Other / unclassified | 1.5 mg | Intrathecal |
| Subject | XT-150 | Other / unclassified | 4.5 mg | Intrathecal |