At a glance
ClinicalIndex Comparison RecordEarly 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.
Safety and Tolerance of RAG-17 in Amyotrophic Lateral Sclerosis Patients With SOD1 Gene Mutation
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
CollaboratorsRactigen Therapeutics.
Timeline
Early Ph 1CompletedFinished
202420252026
Enrollment StartMay 2023
First PostedJun 2023
Primary CompletionJul 2024
TodayJul 2026
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