Amyotrophic Lateral Sclerosis (ALS)Phase 1NCT06704347
Safety Study of XT-150 in Participants With ALS
A Phase 1 study testing XT-150 in people with Amyotrophic Lateral Sclerosis (ALS), run by Xalud Therapeutics, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- XT-150
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2027to Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Have an implanted shunt to drain cerebrospinal fluid (CSF) or an implanted CNS catheter
- Have an implanted of diaphragm pacing system
- Tracheostomy
- 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
Show all 12Show fewer
- Presence of an autoimmune condition (for example, rheumatoid arthritis or lupus) requiring treatment or immunodeficiency
- Clinical or laboratory evidence of hepatic or renal disease/injury.
- Taking any prohibited medications
- Women who are pregnant or nursing
- 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.
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21205
Betsy Mosmiller, Sr. Research Program Manager, 410-502-0495, emosmil1@jhmi.edu
Jeffrey Rothstein, MD, PhD
Massachusetts General Hospital
Boston, Massachusetts, 02114
Shyanne Hill, 617-643-5376, mghxaludphase1@mgb.org
Sabrina Paganoni, MD
Henry Ford Health
Detroit, Michigan, 48202
Maria Stotland, RN, CRC, 313-916-3359, mstotla1@hfhs.org
Anne Vallis, BS, MA, CRC, 313-916-1364, Avallis1@hfhs.org
Barrow Neurological Institute (St. Joseph's)
Phoenix, Arizona, 85013
About this study
Official title: 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
Read the detailed description
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.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- XT-150
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XT-150Biological
XT-150 is a small piece of plasmid DNA (genetic material) that produces a variant of the anti-inflammatory cytokine, Interleukin 10 (IL-10).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 1.5 mg XT-150 | Experimental | Participants will be administered 1.5 mg of XT-150 once by intrathecal injection on Day 1. An intrathecal injection is an injection using a thin needle inserted into the spinal canal at the base of your spinal cord performed by your study doctor. Receives: Biological: XT-150 |
| Cohort 2: 4.5 mg XT-150 | Experimental | Participants will be administered 1.5 mg of XT-150 once by intrathecal injection on Day 1. An intrathecal injection is an injection using a thin needle inserted into the spinal canal at the base of your spinal cord performed by your study doctor. Receives: Biological: XT-150 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting adverse events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
Measured: Up to Day 180
Number of participants with clinically significant physical examination findings
Measured: Up to Day 180
Number of participants with clinically significant vital sign abnormalities
Vital signs include temperature, heart rate, respiratory rate and blood pressure
Measured: Up to Day 180
Number of participants with clinically significant laboratory abnormalities
Clinical laboratory assessments include hematology, chemistry, coagulation, lipids, C-reactive protein, erythrocyte sedimentation rate and CSF total protein, cell count and glucose
Measured: Up to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study startMar 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xalud Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704347
- Sponsor's protocol ID
- XT-150-1-0402
- Status last verified
- Jul 2026
- First submitted
- 20 Nov 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06704347
- Acronym / sponsor ID
- XT-150-1-0402
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Xalud Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2027 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 1.5 mg XT-150 | Experimental | Biological: XT-150Participants will be administered 1.5 mg of XT-150 once by intrathecal injection on Day 1. An intrathecal injection is an injection using a thin needle inserted into the spinal canal at the base of your spinal cord performed by your study doctor. |
| Cohort 2: 4.5 mg XT-150 | Experimental | Biological: XT-150Participants will be administered 1.5 mg of XT-150 once by intrathecal injection on Day 1. An intrathecal injection is an injection using a thin needle inserted into the spinal canal at the base of your spinal cord performed by your study doctor. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- Have an implanted shunt to drain cerebrospinal fluid (CSF) or an implanted CNS catheter
- Have an implanted of diaphragm pacing system
- Tracheostomy
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XT-150XT-150 is a small piece of plasmid DNA (genetic material) that produces a variant of the anti-inflammatory cytokine, Interleukin 10 (IL-10). | Biological | Cohort 1: 1.5 mg XT-150, Cohort 2: 4.5 mg XT-150 |
Primary outcome
Number of participants reporting adverse events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
Time frame: Up to Day 180
Number of participants with clinically significant physical examination findings
Time frame: Up to Day 180
Number of participants with clinically significant vital sign abnormalities
Time frame: Up to Day 180
Vital signs include temperature, heart rate, respiratory rate and blood pressure
Number of participants with clinically significant laboratory abnormalities
Time frame: Up to Day 180
Clinical laboratory assessments include hematology, chemistry, coagulation, lipids, C-reactive protein, erythrocyte sedimentation rate and CSF total protein, cell count and glucose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XT-150 in people with Amyotrophic Lateral Sclerosis (ALS), run by Xalud Therapeutics, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Director of Medical Information (212-301-6673, medical.information@xaludthera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants reporting adverse events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) (time frame: Up to Day 180). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.