CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 6 enrolled
Drug / intervention
RAG-17drug
Likely dose
RAG-17 60mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05903690
NCT05903690Early Ph 1Completed

Safety and Tolerance of RAG-17 in Amyotrophic Lateral Sclerosis Patients With SOD1 Gene Mutation

Beijing Tiantan Hospital·interventional·Posted Jun 15, 2023·Updated Apr 24, 2025

In Brief

A Early Phase 1 clinical trial evaluating RAG-17 for Gene Mutation. Completed, enrolled 6 participants across 1 site.

Detailed Summary

The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics of RAG-17 in adult amyotrophic lateral sclerosis (ALS) patients with SOD1 mutation. Patients will receive drug treamtent via dose escalation which ranging from minimum of 60 mg to the maximum tolerated dose (MTD), after reaching the tolerated dose, a fixed dose of the drug is given once every two months for continuous treatment, and the total treatment cycle is 8 months. The duration of this study is two years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGene Mutation
CountriesChina

Timeline

Early Ph 1CompletedFinished
202420252026
First PostedJun 15, 2023
Enrollment StartMay 24, 2023
Primary CompletionJul 11, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 3.0 years ago

Interventions

RAG-17drug

RAG-17 60mg is used