First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS)
First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of Intrathecally Administered ALN-SOD in Participants With Amyotrophic Lateral Sclerosis and SOD1 Mutations
Sponsor: Regeneron Pharmaceuticals
A PHASE1/PHASE2 clinical study on Amyotrophic Lateral Sclerosis (ALS) and Mutation in the Superoxide Dismutase-1 (SOD1) Gene, this trial is actively recruiting participants. The trial is conducted by Regeneron Pharmaceuticals and has accumulated 11 data snapshots since 2024. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Status Flow
Change History
11 versions recorded-
Feb 2026 — Present [monthly]
Recruiting PHASE1/PHASE2
Phase: PHASE1 → PHASE1/PHASE2
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Oct 2025 — Feb 2026 [monthly]
Recruiting PHASE1
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Sep 2025 — Oct 2025 [monthly]
Recruiting PHASE1
-
Jun 2025 — Sep 2025 [monthly]
Recruiting PHASE1
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Mar 2025 — Jun 2025 [monthly]
Recruiting PHASE1
▶ Show 6 earlier versions
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Jan 2025 — Mar 2025 [monthly]
Recruiting PHASE1
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Dec 2024 — Jan 2025 [monthly]
Recruiting PHASE1
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Oct 2024 — Dec 2024 [monthly]
Recruiting PHASE1
Status: Not Yet Recruiting → Recruiting
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Sep 2024 — Oct 2024 [monthly]
Not Yet Recruiting PHASE1
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Jul 2024 — Sep 2024 [monthly]
Not Yet Recruiting PHASE1
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May 2024 — Jul 2024 [monthly]
Not Yet Recruiting PHASE1
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Regeneron Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Birtinya, Australia , Concord, Australia , Edmonton, Canada , Kaohsiung City, Taiwan , Kyoto, Japan , Leuven, Belgium , London, Canada , Montreal, Canada , Sapporo, Japan , Seoul, South Korea and 5 more locations