NCT07169175
A Phase Ⅰ/Ⅱa Study of SNUG01 in Adult Subjects With ALS
Not Yet Recruiting · Phase 1, Phase 2 · SineuGene Therapeutics Co., Ltd. · registry updated 2025-09-11
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy of SNUG01 in in adult subjects with Amyotrophic Lateral Sclerosis (ALS).
Inclusion
- Inclusion Criteria\*\*:
- Subjects who are able to provide written informed consent form (ICF).
- Subjects who are males or females must be ≥ 18 years and ≤ 80 years of age at the screening visit.
- Subjects who have clinically definite ALS, clinically probable ALS, or clinically probable-laboratory supported ALS as specified in the revised version of the El Escorial World Federation of Neurology criteria.
- Subjects must have an ALS disease duration (from first symptom onset to the screening visit) ≤ 2 years.
- Subjects with a body mass index (BMI) ≥ 19 kg/m2 at the screening visit.
Exclusion
- Exclusion Criteria\*\*:
- Serum Anti-AAV9 neutralizing antibody titer ≥ 1:100.
- Current or previous exposure to gene therapy, stem cell products, and solid organ transplantation.
- Subjects who have implanted or are estimated to require a diaphragmatic pacing system during the study period.
- Any thromboembolic event, such as deep vein thrombosis, pulmonary arteriovenous embolism, and jugular vein embolism, has occurred within 6 months before the administration.
- Suffering from autoimmune diseases or ongoing immune-related therapy, except intranasal, inhalation, ocular, topical, intra-articular corticosteroid therapy or corticosteroid physiological replacement therapy.