Clinical Trial

A Study of SGT-212 Gene Therapy in Friedreich's Ataxia

Study acronym: FALCON
Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
This is a phase 1b, first in-human, open-label, dose-finding study investigating the safety and tolerability of SGT-212 in participants with Friedreich's ataxia (FA). It will be delivered via dual intradentate nucleus (IDN) and intravenous (IV) administration to participants with FA. All participants will receive SGT-212 and will be enrolled in the study for approximately 5 years.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2025-09-11; most recent amendment 2026-06-17.
Status change: Not Yet Recruiting → Recruiting 2025-12-02
Trial Details
NCT Number NCT07180355
Lead Sponsor Solid Biosciences Inc.
Conditions Friedreich's Ataxia (FA)
Enrollment 10 participants
Start Date 2025-10-22
Primary Completion 2028-03-21 (estimated)
Study Completion 2032-02-29 (estimated)
Updated on ClinicalTrials.gov 2026-07-30