NCT07221240

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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Amisodin in Healthy Adult Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: PRG Science & Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

During this trial, a total of 48 subjects will be randomized in a 3:1 ratio (out of 8 subjects, 6 on Amisodin, 2 on placebo in each dose group). The placebo is a capsule that looks like Amisodin but contains no study drug. The use of a placebo helps to make sure that any side effects during the study are judged fairly. In Part 1 (SAD), subjects will receive a single oral dose of Amisodin or placebo under fasting conditions, with one cohort crossing over to receive the same treatment under fed conditions to assess the effect of food. In Part 2 (MAD), subjects will receive Amisodin or placebo once daily for 7 days under fasting conditions. Dose escalation in both parts will proceed only after safety and tolerability are confirmed by the Safety Review Committee (SRC). Safety assessments will include adverse events (AEs), ECGs, vital signs, laboratory tests, physical examinations, and C-SSRS evaluations, while plasma samples will be collected to evaluate PK. Amisodin will be administered study drug or placebo with approximately 180mL of water under fasting conditions. The capsules will be opened and mixed with 60mL of water. The contents will be stirred well to create a uniform suspension for consumption and immediately administered orally as one dose to the subject. The cup/bottle will be rinsed with an additional 60mL of water and immediately administered to the subject. A second rinse with an additional 60mL of water will be performed and immediately administered to the subject.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	Amisodin	Administered as specified in the treatment arm.
OTHER	Placebo	Administered as specified in the Placebo arm.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-05-27
• Completion: 2026-07-03
• First posted: 2025-10-27
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study