Safety Study of XT-150 in Participants With ALS
ConditionAmyotrophic Lateral Sclerosis (ALS)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXalud Therapeutics, Inc.
About 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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- XT-150
Treatment groups
8 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov