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)
Xalud Therapeutics, Inc.
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
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 b…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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 ar…
Interventions
- BiologicalXT-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).
Locations (4)
- Barrow Neurological Institute (St. Joseph's)Phoenix, Arizona
- Johns Hopkins UniversityBaltimore, Maryland
- Massachusetts General HospitalBoston, Massachusetts
- Henry Ford HealthDetroit, Michigan