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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RAG-17 in Subjects With Amyotrophic Lateral Sclerosis (ALS) With Superoxide Dismutase Type 1 (SOD1) Gene Mutation

NCT06556394 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-01-08

No results posted yet for this study

Summary

This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RAG-17 in Subjects with Amyotrophic Lateral Sclerosis (ALS) with Superoxide Dismutase Type 1 (SOD1) Gene Mutation

Conditions

Interventions

DRUG

RAG-17

RAG-17 is a therapeutic small interfering RNA (siRNA).

DRUG

Placebo

Placebo will be administered via intrathecal injection

Sponsors & Collaborators

  • Ractigen Therapeutics.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-24
Primary Completion
2026-02-28
Completion
2026-04-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT06556394 on ClinicalTrials.gov