NCT06704347Not yet recruitingPhase 1
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)
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (estimated)
- First submitted
- 20 Nov 2024
- Start date
- 1 Mar 2027
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Xalud Therapeutics, Inc.
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06704347
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 8
- From 1 Mar 2027 to the primary completion date, 30 Jun 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Lab values
- Clinical or laboratory evidence of hepatic or renal disease/injury.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Henry Ford Health Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Barrow Neurological Institute (St. Joseph's) Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.