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NOT YET RECRUITING
NCT07077668
EARLY_PHASE1

Extended Study of RAG-17 in the Treatment of Amyotrophic Lateral Sclerosis Patients With SOD1 Gene Mutation

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

This study primarily evaluates the safety, tolerability, and efficacy of RAG - 17 in adult ALS patients with SOD1 - mutated genes in the real - world setting.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-07

Completion Date

2026-12-31

Last Updated

2025-07-22

Healthy Volunteers

No

Interventions

DRUG

A sterile aqueous solution of RAG - 17 preparation (sodium salt)

Patients who meet the inclusion and exclusion criteria are required to come to the hospital at the following time points to complete the intrathecal bolus injection of RAG - 17 for 150 mg: baseline, 60 ± 3 days, 120 ± 3 days, 180 ± 3 days, 240 ± 3 days, 300 ± 3 days, 360 ± 3 days, 450 ± 3 days, 540 ± 3 days.