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NOT YET RECRUITING

NCT06704347

PHASE1

Safety Study of XT-150 in Participants With ALS

Sponsor: Xalud Therapeutics, Inc.

View on ClinicalTrials.gov

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. 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

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)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-11

Completion Date

2027-03

Last Updated

2025-04-06

Healthy Volunteers

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Interventions

BIOLOGICAL

XT-150

XT-150 is a small piece of plasmid DNA (genetic material) that produces a variant of the anti-inflammatory cytokine, Interleukin 10 (IL-10).

Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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 * 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

Locations (4)

Barrow Neurological Institute (St. Joseph's)

Phoenix, Arizona, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Henry Ford Health

Detroit, Michigan, United States