Safety Study of XT-150 in Adults With ALS
Tests a single injection of XT-150 for safety in adults with ALS.
Plain-language title generated from the registry record
Registry title: Safety Study of XT-150 in Participants With ALS
Key facts
- Where
- Baltimore, Boston, Detroit, and Phoenix, United StatesSee the 4 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06704347, who can take part
Where in United States
- Johns Hopkins UniversityBaltimore, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- Henry Ford HealthDetroit, United StatesNo longer taking part
- Barrow Neurological Institute (St. Joseph's)Phoenix, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xalud Therapeutics, Inc.
- Trial code
- NCT06704347
- Record updated
- 29 July 2026
- Original description
This is a Phase 1, open-label, multi-center safety study of XT-150 in adult participants with Amyotrophic Lateral Sclerosis (ALS).Read full original descriptionShow less
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
Inclusion: Adults between 18 and 80 years of age; Male or female, if of childbearing potential or sexually active, strict contraception required; Have ALS diagnosed by a doctor (specifically, sporadic or familial ALS diagnosed as clinically probable, lab-supported probable or definite ALS defined by the El Escorial criteria); Have had symptoms of ALS (muscle weakness) within 36 months of starting this study; Have the ability to slowly exhale a volume of air at least 60% of what is expected for the participant's sex, height and age; Have not received treatment for ALS or are currently on a stable dose of an approved treatment for ALS. Patients currently receiving Tofersen are not eligible; Able to receive the study injection intrathecally, determined by the study doctor; Able to undergo the study procedures and adhere to the study visit schedule at the time of study entry, with an estimated life expectancy of 6 months or greater.
Exclusion: Taking any prohibited medications; Use of any investigational drugs or devices within 30 days or 5 half-lives of the study agent (whichever is longer). Exception: Observational, non-interventional clinical studies are allowed in the opinion of the study doctor; History or current diagnosis of cardiac conditions or ECG abnormalities indicating significant risk of safety for participants in the study; History or current diagnosis of respiratory conditions such as COPD; History or current diagnosis of cancer, chemical meningitis, HIV, Hep B, Hep C, uncontrolled diabetes; Presence of an autoimmune condition (for example, rheumatoid arthritis or lupus) requiring treatment or immunodeficiency; Any other condition that the study doctor feels could compromise the participant's safety, ability to communicate with the study staff, or the quality of the data; Clinical or laboratory evidence of hepatic or renal disease/injury; Have an implanted shunt to drain cerebrospinal fluid (CSF) or an implanted CNS catheter; Have an implanted of diaphragm pacing system; Tracheostomy; Women who are pregnant or nursing.