Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • XT-150

    Biological/Vaccine

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

Treatment groups

8 Participants
are divided into 2 treatment groups
Group A: Cohort 1: 1.5 mg XT-150Experimental treatment 1 intervention
Group B: Cohort 2: 4.5 mg XT-150Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants reporting adverse events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)

Time frame
Up to Day 180
2

Number of participants with clinically significant physical examination findings

Time frame
Up to Day 180
3

Number of participants with clinically significant vital sign abnormalities

Vital signs include temperature, heart rate, respiratory rate and blood pressure

Time frame
Up to Day 180
4

Number of participants with clinically significant laboratory abnormalities

Clinical laboratory assessments include hematology, chemistry, coagulation, lipids, C-reactive protein, erythrocyte sedimentation rate and CSF total protein, cell count and glucose

Time frame
Up to Day 180

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xalud Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: