XT-150 for ALS

Recruiting at 3 trial locations

Overseen By Director of Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Xalud Therapeutics, Inc.

Must not be taking: Tofersen, Investigational drugs

Disqualifiers: Cardiac conditions, COPD, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 181

Duration: 1 day

8 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you should not be taking any prohibited medications. If you are on a stable dose of an approved ALS treatment, you may continue with it, but you cannot be on Tofersen.

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for adults with Amyotrophic Lateral Sclerosis (ALS), a type of motor neuron disease. Participants must provide informed consent and meet all study requirements to receive a single injection of XT-150 and be followed up for 6 months.

Inclusion Criteria

My doctor says I can get the study injection in my spine.

I have not been treated for ALS or am on a stable dose of an approved ALS treatment, excluding Tofersen.

I can follow the study plan and expect to live 6 months or more.

Exclusion Criteria

Have an implanted of diaphragm pacing system

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

I am not taking any medications that are not allowed in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intrathecal injection of XT-150 at the Baseline visit

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events, vital signs, and laboratory assessments

6 months

Multiple visits over 180 days

Treatment Details

Interventions

• XT-150

Trial Overview The safety of XT-150, given as a single injection, is being tested in ALS patients. This Phase 1 trial will have two groups receiving different doses: one group gets 1.5 mg and another gets 4.5 mg, with each group having four participants.

Participant Groups

Group I: Cohort 2: 4.5 mg XT-150 Experimental Treatment 1 Intervention

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.

Group II: Cohort 1: 1.5 mg XT-150 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Xalud Therapeutics, Inc.

Lead Sponsor

Trials

8

Recruited

450+