drugset / Trial / NCT07290062

A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS)

NCT07290062 ↗

Phase 1 Recruiting 23 enrolled Insmed Gene Therapy LLC
Non-randomizedSequentialOpen-labelTreatment

Summary

The primary objective of this dose-finding study is to evaluate the safety, tolerability and pharmacodynamics of single dose of INS1202 via IT administration in participants ≥ 18 to \<80 years of age with ALS who carry superoxide dismutase type 1 (SOD1) mutations or harbor no known ALS-related genetic mutation.

Timeline

Start
2026-01-09
Primary completion
2030-03-31
Completion
2030-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject INS1202 Unknown — Intrathecal