XT-150 for ALS

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Xalud Therapeutics, Inc.

No Placebo Group

Trial Summary

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

Research Team

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 am between 18 and 80 years old.

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

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.

Treatment Details

Interventions

• XT-150 (Virus Therapy)

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+