Safety Study of XT-150 in Participants With ALS

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Xalud Therapeutics, Inc.
Study ID
NCT06704347
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • XT-150 — BIOLOGICAL
    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 Details

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

Key Dates

Start date
Nov 30, 2025
Status verified
Apr 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
8 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: 1.5 mg XT-150
    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.
  • Experimental: Cohort 2: 4.5 mg XT-150
    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.

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 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Barrow Neurological Institute (St. Joseph's)PhoenixArizona85013-
Johns Hopkins UniversityBaltimoreMaryland21205
Betsy Mosmiller, Sr. Research Program Manager
[email protected]
410-502-0495
Jeffrey Rothstein, MD, PhD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Shyanne Hill
[email protected]
617-643-5376
Sabrina Paganoni, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford HealthDetroitMichigan48202
Maria Stotland, RN, CRC
[email protected]
313-916-3359
Anne Vallis, BS, MA, CRC
[email protected]
313-916-1364
Ximena Arcila-Londono, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
Barrow Neurological Institute (St. Joseph's)· Phoenix, AZJohns Hopkins University· Baltimore, MDMassachusetts General Hospital· Boston, MAHenry Ford Health· Detroit, MI

Related Studies