# First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS)

> **NCT06351592** · PHASE1,PHASE2 · RECRUITING · sponsor: **Regeneron Pharmaceuticals** · enrollment: 42 (estimated)

## Conditions studied

- Amyotrophic Lateral Sclerosis (ALS)
- Mutation in the Superoxide Dismutase-1 (SOD1) Gene

## Interventions

- **DRUG:** ALN-SOD
- **OTHER:** Diluent
- **DRUG:** Placebo (PB)

## Key facts

- **NCT ID:** NCT06351592
- **Lead sponsor:** Regeneron Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2024-08-28
- **Primary completion:** 2031-06-05
- **Final completion:** 2031-06-05
- **Target enrollment:** 42 (ESTIMATED)
- **Last updated:** 2026-02-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06351592

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06351592, "First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS)". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT06351592. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*