Clinical Trial

Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Amisodin in Healthy Adult Subjects With Amyotrophic Lateral Sclerosis

Study acronym: ALS
Recruiting Phase 1
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Record status
This record was last updated March 5, 2026 (before its estimated May 27, 2026 completion). Its status may not reflect the trial's current state.
Summary
Researchers will evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered Amisodin in healthy adult subjects through a randomized, double-blind, placebo-controlled Phase 1 study consisting of two parts: single ascending dose (SAD) and multiple ascending dose (MAD). The food effect will be assessed in one cohort in Part1. Approximately 48 healthy, adult subjects are planned to be enrolled in total. Subjects will participate in only one part and one cohort.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-10-24; most recent amendment 2026-03-03.
Trial Details
NCT Number NCT07221240
Lead Sponsor PRG Science & Technology Co., Ltd.
Conditions Amyotrophic Lateral Sclerosis
Enrollment 48 participants
Start Date 2025-10-01
Primary Completion 2026-05-27 (estimated)
Study Completion 2026-07-03 (estimated)
Updated on ClinicalTrials.gov 2026-03-05