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An IIT Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of a Single Intrathecal Injection of SNUG01 in Patients with Amyotrophic Lateral Sclerosis

NCT06645197 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-10-16

No results posted yet for this study

Summary

This is a multicenter, open-label, single-arm investigator-initiated clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of SNUG01 in patients with Amyotrophic Lateral Sclerosis (ALS).

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

DRUG

SNUG01

Recombinant adeno-associated virus serotype 9 capsid containing human SG001 expression cassette

Sponsors & Collaborators

  • SineuGene Therapeutics Co., Ltd.

    collaborator INDUSTRY

  • Peking University Third Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-16
Primary Completion
2025-04-15
Completion
2029-10-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06645197 on ClinicalTrials.gov