A Phase Ⅰ/Ⅱa Study of SNUG01 in Adult Subjects With ALS

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
SineuGene Therapeutics Co., Ltd.
Study ID
NCT07169175
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • SNUG01 — DRUG
    AAV (adeno-associated virus) Gene therapy

Study Details

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).

Key Dates

Start date
Dec 1, 2025
Status verified
Sep 2025
Primary completion
Mar 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 3 Ascending Dose Levels, Single Injection by Intrathecal(IT)

Primary Outcome Measure

The safety and tolerability of SNUG01 administered by intrathecal. [ Time Frame: up to 1 year after administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02467-

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