SNUG01 for ALS
Recruiting at 3 trial locations
JS
Overseen ByJi Shen
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: SineuGene Therapeutics Co., Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Are You a Good Fit for This Trial?
This trial is for adults with Amyotrophic Lateral Sclerosis (ALS). Specific eligibility criteria are not provided, but typically include factors like disease stage and overall health. People who meet certain conditions that the study outlines may be excluded.Inclusion Criteria
I have been diagnosed with ALS according to specific medical criteria.
Subjects who are able to provide written informed consent form (ICF)
I am between 18 and 80 years old.
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Exclusion Criteria
Serum Anti-AAV9 neutralizing antibody titer ≥ 1:100
Subjects who have implanted or are estimated to require a diaphragmatic pacing system during the study period
I have been treated with gene therapy, stem cell products, or had an organ transplant.
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Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation and Expansion
Participants receive ascending dose levels of SNUG01 via single intrathecal injection
52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
up to 1 year
What Are the Treatments Tested in This Trial?
Interventions
- SNUG01
Trial Overview The trial is testing SNUG01's safety, how well patients can tolerate it, and its initial effectiveness in treating ALS. This involves observing any changes in the condition or symptoms of ALS after administering SNUG01.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: 3 Ascending Dose Levels, Single Injection by Intrathecal(IT)Experimental Treatment1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
SineuGene Therapeutics Co., Ltd.
Lead Sponsor
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